510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation

K232610510(k) TraditionalCleared Mar 14, 2024199-day reviewClass II21 CFR 876.1500Recalls 6

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument

Cleared on Mar 14, 2024 as substantially equivalent to K131861 (Intuitive Surgical, Inc., 2014) and 22 other predicates after a 199-day review. Its family tree reaches back 24 generations to 1994. 3 of the 155 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it. It has been recalled 6 times.

Decided
Mar 14, 2024
Review
199 days
Class
Class II
Product code
NAY
Recalls
6
Predicates
24

Its longest line of descent runs back 24 generations to K930667 (1994). 143 ancestors in all, the oldest K811390 (1981). 11 later devices descend from it, 7 citing it directly. 3 of the 155 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2023: 1 other ancestor2020: 2 other ancestors2019: 1 other ancestor2018: 3 other ancestors2017: 5 other ancestors2016: 5 other ancestors2014: 2 other ancestors2013: 1 other ancestor2011: 4 other ancestors, 1 with a Class I recall12015: 2 other ancestors2009: 2 other ancestors2006: 7 other ancestors2005: 3 other ancestors2004: 5 other ancestors2002: 6 other ancestors, 1 with a Class I recall12001: 8 other ancestors2012: 2 other ancestors, 1 with a Class I recall12008: 2 other ancestors2007: 6 other ancestors2003: 7 other ancestors1999: 8 other ancestors1997: 10 other ancestors1993: 2 other ancestors1991: 5 other ancestors2000: 2 other ancestors1998: 4 other ancestors1996: 3 other ancestors1995: 3 other ancestors1994: 4 other ancestors1992: 1 other ancestor1990: 1 other ancestor1988: 1 other ancestor1981: 1 other ancestor2026: 5 descendants cleared2025: 4 descendants cleared2024: 2 descendants clearedReference device: K171120 · Senhance Surgical Robotic System · Transenterix, Inc. · 2017Reference device: K190303 · AirSeal · Conmed Corporation · 2019K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalled×5: 5 generations cleared close together, K040237 (2004), K043153 (2004), K050005 (2005), K050404 (2005), K050802 (2005) K063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK090993 · Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK123463 · Intuitive Surgical DA Vinci SI Surgical System Smartpedals · Intuitive Surgical, Inc. · 2012 · recalledK131861 · DA Vinci Surgical System, Endowrist Instruments and Accessories · Intuitive Surgical, Inc. · 2014 · recalled×2: 2 generations cleared close together, K152578 (2016), K153276 (2016) ×2: 2 generations cleared close together, K170713 (2017), K171632 (2017) K173842 · da Vinci Xi Surgical System, da Vinci X Surgical System · Intuitive Surgical, Inc. · 2018K182140 · da Vinci Xi Surgical System, da Vinci X Surgical System · Intuitive Surgical, Inc. · 2018K183086 · da Vinci X and Xi Surgical System · Intuitive Surgical, Inc. · 2020K202834 · da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) · Intuitive Surgical, Inc. · 2020K211784 · da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) · Intuitive Surgical, Inc. · 2021K223080 · da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) · Intuitive Surgical, Inc. · 202219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 12 other ancestors2 generations back: 5 other ancestors3 generations back: 16 other ancestors4 generations back: 19 other ancestors, 1 with a Class I recall15 generations back: 35 other ancestors, 1 with a Class I recall16 generations back: 20 other ancestors, 1 with a Class I recall17 generations back: 11 other ancestors8 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 4 descendants K223080 · da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) · Intuitive Surgical, Inc. · 2022K211784 · da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) · Intuitive Surgical, Inc. · 2021K202834 · da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) · Intuitive Surgical, Inc. · 2020K183086 · da Vinci X and Xi Surgical System · Intuitive Surgical, Inc. · 2020K182140 · da Vinci Xi Surgical System, da Vinci X Surgical System · Intuitive Surgical, Inc. · 2018K173842 · da Vinci Xi Surgical System, da Vinci X Surgical System · Intuitive Surgical, Inc. · 2018K171632 · da Vinci Xi Surgical System · Intuitive Surgical, Inc. · 2017K170713 · da Vinci Xi Surgical System · Intuitive Surgical, Inc. · 2017K153276 · da Vinci Xi Surgical System · Intuitive Surgical, Inc. · 2016K152578 · da Vinci Surgical System, Model IS4000 · Intuitive Surgical, Inc. · 2016K131861 · DA Vinci Surgical System, Endowrist Instruments and Accessories · Intuitive Surgical, Inc. · 2014 · recalledK123463 · Intuitive Surgical DA Vinci SI Surgical System Smartpedals · Intuitive Surgical, Inc. · 2012 · recalledK090993 · Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK081137 · Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 · Intuitive Surgical, Inc. · 2009 · recalledK063220 · DA Vinci S Surgical System-V1.1, Model IS2000 · Intuitive Surgical, Inc. · 2006 · recalledK050802 · Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050404 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2005K050005 · Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model 400180 · Intuitive Surgical, Inc. · 2005 · recalledK043153 · Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000 · Intuitive Surgical, Inc. · 2004K040237 · Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments · Intuitive Surgical, Inc. · 2004K021036 · Intuitive Surgical DA Vinci Surgical System, Model IS1000 · Intuitive Surgical, Inc. · 2002 · recalledK990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalled−20−15−10−50
  1. Root · 24 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 20 generations between
  3. 3 generations backK202834 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System…Intuitive Surgical, Inc. · 2020
  4. 2 generations backK211784 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System…Intuitive Surgical, Inc. · 2021
  5. 1 generation backK223080 da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System…Intuitive Surgical, Inc. · 2022
  6. This deviceK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024
  7. Descendant · cites it directly · 2 of its ownK251739 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2026
  8. Descendant · cites it directly · 2 of its ownK241284 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024
  9. Descendant · cites it directly · 1 of its ownK251202 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2025
  10. Descendant · cites it directly · 1 of its ownK243641 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024
  11. Descendant · 2 generations on · 0 of its ownK261823 da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
Show all 24 generations
  1. Root · 24 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 23 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 22 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 21 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 20 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 19 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 18 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 17 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. 16 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. 15 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. 14 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. 13 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
  13. 12 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
  14. 11 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
  15. 10 generations backK152578 da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc. · 2016
  16. 9 generations backK153276 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2016
  17. 8 generations backK170713 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2017
  18. 7 generations backK171632 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2017
  19. 6 generations backK173842 da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018
  20. 5 generations backK182140 da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018
  21. 4 generations backK183086 da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc. · 2020
  22. 3 generations backK202834 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System…Intuitive Surgical, Inc. · 2020
  23. 2 generations backK211784 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System…Intuitive Surgical, Inc. · 2021
  24. 1 generation backK223080 da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System…Intuitive Surgical, Inc. · 2022
  25. This deviceK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2024: 22025: 42026: 5
2024high 5 (2026) · low 2 (2024)2026

Class I recalls in this family

  • K122180 High Flow Insufflantion Unit4 generations back · 2012
  • K110294 High Flow Insufflation Unit Uhi-45 generations back · 2011
  • K014166 Uhi-3 High Flow Insufflation Unit6 generations back · 2002

Most influential descendants

Showing 5 of 11 · See all
  • K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2026 · cites it directly2descendants
  • K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024 · cites it directly2descendants
  • K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2025 · cites it directly1descendant
  • K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024 · cites it directly1descendant
  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−24K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−23K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−22K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−21K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−20K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−19K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−18K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−17K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
−16K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
−15K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
−14K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
−13K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200…Intuitive Surgical, Inc.20093
−12K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20122
−11K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201480
−10K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.2016—
−9K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.2016—
−8K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.2017—
−7K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.2017—
−6K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.2018—
−5K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.2018—
−4K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc.2020—
−3K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.2020—
−2K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc.2021—
−1K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc.2022—
0 (this device)K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with…Intuitive Surgical, Inc.2024—
+1K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.2026—
+1K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.2024—
+1K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.2025—
+1K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.2024—
+2K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199010
199150
199210
199320
199440
199530
199630
1997100
199840
199980
200020
200180
200261
200370
200450
200530
200670
200760
200820
200920
201141
201221
201310
201420
201520
201650
201750
201830
201910
202020
202310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202420
202540
202650
FIG. 1 — Lineage of K232610, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NAY device

  1. #1 K243714 da Vinci SP Surgical System (SP1098)score 27.5 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (24)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K131861DA Vinci Surgical System, Endowrist Instruments and Accessories
Summary page 6
…Obstetrics and Gynecology General Hospital Predicate Devices: Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, with subsequent clearances for additional features, instruments, accessories – K14…
Intuitive Surgical, Inc.201480
*K141077DA Vinci Firefly Imaging System
Summary page 6
…inci Surgical System, Model IS4000 (K131861, with subsequent clearances for additional features, instruments, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632…
Intuitive Surgical, Inc.20142
*K151794da Vinci Xi Surgical System
Summary page 6
…ical System, Model IS4000 (K131861, with subsequent clearances for additional features, instruments, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699…
Intuitive Surgical, Inc.2016—
*K152892da Vinci Xi Surgical System
Summary page 6
…em, Model IS4000 (K131861, with subsequent clearances for additional features, instruments, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086…
Intuitive Surgical2016—
*K161271da Vinci Xi Surgical System
Summary page 6
…IS4000 (K131861, with subsequent clearances for additional features, instruments, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643…
Intuitive Surgical, Inc.2016—
*K191529da Vinci Xi Surgical System, da Vinci X Surgical System
Summary page 6
…K131861, with subsequent clearances for additional features, instruments, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643,…
Intuitive Surgical2020—
*K152578da Vinci Surgical System, Model IS4000
Summary page 6
…for additional features, instruments, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K20283…
Intuitive Surgical, Inc.2016—
*K153276da Vinci Xi Surgical System
Summary page 6
…tional features, instruments, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K21178…
Intuitive Surgical, Inc.2016—
*K161178da Vinci Xi Surgical System
Summary page 6
…atures, instruments, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K22308…
Intuitive Surgical, Inc.2017—
*K170713da Vinci Xi Surgical System
Summary page 6
…nstruments, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K23122…
Intuitive Surgical, Inc.2017—
*K171632da Vinci Xi Surgical System
Summary page 6
…s, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224)…
Intuitive Surgical, Inc.2017—
*K171699da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System
Summary page 6
…ories – K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224)…
Intuitive Surgical, Inc.2017—
Kept off the family treeK172086FDA’s K172086 is Matira™ Anterior Cervical System
Our reading of the summary gave K172086, FDA’s number for Matira™ Anterior Cervical System (Kalitec Direct, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intuitive Surgical da Vinci Surgical System, Model IS4000”. Kept off the family tree.
Summary page 6
…K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) W…
Kalitec Direct, LLC2017—
*K172643da Vinci Xi Surgical System; da Vinci X Surgical System
Summary page 6
…K141077, K151794, K152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) World of M…
Intuitive Surgical, Inc.2018—
*K173585da Vinci Xi Surgical System, da Vinci X Surgical System
Summary page 6
…152892, K161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) World of Medicine Pneumoclear Insufflation…
Intuitive Surgical, Inc.2018—
*K173842da Vinci Xi Surgical System, da Vinci X Surgical System
Summary page 6
…161271, K191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) World of Medicine Pneumoclear Insufflation System (…
Intuitive Surgical, Inc.2018—
*K182140da Vinci Xi Surgical System, da Vinci X Surgical System
Summary page 6
…191529; and representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) World of Medicine Pneumoclear Insufflation System (K201361)…
Intuitive Surgical, Inc.2018—
*K183086da Vinci X and Xi Surgical System
Summary page 6
…nd representative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) World of Medicine Pneumoclear Insufflation System (K201361)…
Intuitive Surgical, Inc.2020—
*K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Summary page 6
…entative uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) World of Medicine Pneumoclear Insufflation System (K201361)…
Intuitive Surgical, Inc.2020—
*K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Summary page 6
…uses - K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) World of Medicine Pneumoclear Insufflation System (K201361) Endo…
Intuitive Surgical, Inc.2021—
*K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
Summary page 6
…K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) World of Medicine Pneumoclear Insufflation System (K201361) Endoscope Ste…
Intuitive Surgical, Inc.2022—
*K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)
Summary page 6
…K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) World of Medicine Pneumoclear Insufflation System (K201361) Endoscope Sterilizatio…
Intuitive Surgical, Inc.2023—
*K201361Pneumoclear
Summary page 6
…K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224) World of Medicine Pneumoclear Insufflation System (K201361) Endoscope Sterilization Tray (K183139) ©2024 Intuitive Surgical…
W.O.M. World of Medicine GmbH2020—
*K183139Endoscope Sterilization Tray
Summary page 6
…02834, K211784, K223080, K231224) World of Medicine Pneumoclear Insufflation System (K201361) Endoscope Sterilization Tray (K183139) ©2024 Intuitive Surgical, Inc. All rights reserved. Product names…
Intuitive Surgical, Inc.20191
†K171120Senhance Surgical Robotic SystemTransenterix, Inc.2017—
†K190303AirSealConmed Corporation2019—

Also cleared against K131861: 31 other devices →

What descends from it? (11)

See all 11

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20262
K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20242
K251202da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20251
K243641da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20241
K251227da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250
K250442da Vinci Surgical System, IS5000Intuitive Surgical, Inc.20250
K251213Da Vinci Surgical System (IS5000)Intuitive Surgical, Inc.20250

Has anything in its family been recalled? (3 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 24, 2026Class IIZ-2310-2026Device DesignDue to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
Dec 30, 2025Class IIZ-1355-2026Process change controlRobotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization…
Nov 17, 2025Class IIZ-1428-2026Software Design ChangeAn error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Nov 7, 2025Class IIZ-1232-2026Process controlDue to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws…
Feb 26, 2025Class IIZ-1325-2025Device DesignDue to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
Aug 21, 2024Class IIZ-0964-2026Device DesignSurgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci…

The 5 latest of 6 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 4 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
  • K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 5 generations back · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall
  • K014166Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 37 of the 143 ancestors have a recall of any class; 3 have a Class I recall.
  • Of its descendants, K251739 (Intuitive Surgical, Inc., 2026) has gone furthest, with 2 descendants of its own.
  • 31 other devices also cite its predicate K131861.

How does its category compare?

All NAY devices

NAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · NAY

16in 2025

2008: 42009: 32010: 12011: 72012: 42013: 42014: 92015: 32016: 82017: 162018: 152019: 82020: 92021: 112022: 62023: 52024: 102025: 162026 (partial year): 7
2007high 16 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NAY

117in 2025

2008: 189 days median2009: 253 days median2011: 191 days median2012: 106 days median2013: 144 days median2014: 143 days median2015: 99 days median2016: 197 days median2017: 107 days median2018: 152 days median2019: 73 days median2020: 212 days median2021: 61 days median2022: 57 days median2023: 141 days median2024: 126 days median2025: 117 days median2026 (partial year): 89 days median
2007high 253 (2009) · low 57 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NAY

1in 2025

2007: 112008: 32009: 12011: 22012: 12013: 62014: 252015: 32016: 12017: 12018: 22019: 52021: 32022: 32023: 2, 1 Class I2024: 402025: 12026 (partial year): 4, 1 Class I
2007high 40 (2024) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NAY

48,456in 2025

2007: 1332008: 2242009: 3802010: 6232011: 5012012: 1,5522013: 6,2172014: 6,1352015: 1,7222016: 1,0772017: 1,0492018: 1,0742019: 1,1542020: 1,5582021: 1,9972022: 5,7272023: 10,8982024: 12,8722025: 48,456
2007high 48,456 (2025) · low 133 (2007)2025

MAUDE reports naming product code NAY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—11133
200841893224
200932531380
20101—0623
201171912501
2012410611,552
2013414466,217
20149143256,135
201539931,722
2016819711,077
20171610711,049
20181515221,074
201987351,154
2020921201,558
2021116131,997
202265735,727
202351412 (1)10,898
2024101264012,872
202516117148,456
20267894 (1)—

What is it indicated for?

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection…

Read the full statement (396 words)

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.

It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Contraindication:

Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

The da Vinci Insufflator with compatible tube sets is intended for use in diagnostic and/or therapeutic endoscopic and thoracoscopic procedures to distend a cavity by filling it with gas. Intended cavities for this device include abdominal and thoracic cavities in adult and bariatric patients.

The Intuitive da Vinci 5 endoscope tray is intended for use to encase and protect compatible da Vinci endoscopes for sterilization in any of the following sterilization machines and cycles:

• STERRAD 100NX sterilization system using the Flex, Express, and DUO cycles

• STERIS V-PRO maX 2 using the Non Lumen, Flexible, or Lumen cycles

• STERIS V-PRO maX using the Non Lumen, Flexible, or Lumen cycles

• STERIS V-PRO 1 Plus using the Non Lumen or Lumen cycles

• STERIS V-PRO 1 using the V-PRO/Lumen cycle

The sterilization-cycle parameters of the sterilizers are preset by the manufacturers and are not adjustable. The maximum product load per tray is one da Vinci 5 endoscope. The length of the da Vinci 5 endoscopes is approximately 600 mm and the diameter of the shaft is 8.8 mm. The maximum weight of the tray and endoscope is 13 lbs. The endoscope tray is not intended to maintain sterility; it is intended to be used in conjunction with a legally-marketed, validated, FDA-cleared STERRAD and STERIS V-PRO compatible sterilization wrap in order to maintain sterility of the enclosed medical instrument.

Indications for use as stated in the FDA summary.

Also cleared against K131861

31 other devices cite the same predicate.

  • K252926Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent…Restore Robotics · 2026
  • K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc. · 2025
  • K240723da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)Intuitive Surgical · 2024
  • K231224da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc. · 2023
  • K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc. · 2022
  • K2200238mm Monopolar Curved ScissorsIntuitive Surgical, Inc. · 20221 recall

More from Intuitive Surgical, Inc.

181 FDA decisions under this applicant name. See the company

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261249Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026

Recent decisions in NAY

The NAY category page

  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K260695da Vinci Firefly Imaging SystemIntuitive Surgical · 2026
  • K254192Senhance Ultrasonic SystemAsensus Surgical · 2026
  • K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc. · 2026

https://510kreport.com/device/K232610 · printed Nov 4, 2026

Cite this page

510(k) Report. “K232610: da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232610

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026