510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

DA Vinci Surgical System, Endowrist Instruments and Accessories

K131861510(k) TraditionalCleared Mar 28, 2014277-day reviewClass II21 CFR 876.1500Recalls 80

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 28, 2014 as substantially equivalent to K090993 (Intuitive Surgical, Inc., 2009) and 1 other predicate after a 277-day review. Its family tree reaches back 13 generations to 1994. 1 of the 179 devices in its family, counting itself, has a Class I recall. 124 later devices descend from it. It has been recalled 80 times.

Decided
Mar 28, 2014
Review
277 days
Class
Class II
Product code
NAY
Recalls
80
Predicates
3

Its longest line of descent runs back 13 generations to K930667 (1994). 54 ancestors in all, the oldest K811390 (1981). 124 later devices descend from it, 32 citing it directly. 1 of the 179 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2006: 2 other ancestors2005: 2 other ancestors2004: 4 other ancestors2002: 3 other ancestors2001: 5 other ancestors2003: 1 other ancestor1999: 3 other ancestors1997: 7 other ancestors1993: 2 other ancestors1998: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestors1992: 1 other ancestor1991: 3 other ancestors1988: 1 other ancestor1981: 1 other ancestor2017: 7 descendants cleared2014: 2 descendants cleared2025: 19 descendants cleared2024: 14 descendants cleared2016: 7 descendants cleared2018: 7 descendants cleared2015: 2 descendants cleared2020: 9 descendants cleared2021: 9 descendants cleared2022: 12 descendants cleared2026: 17 descendants cleared2023: 15 descendants cleared, 1 with a Class I recall12019: 4 descendants clearedK930667 · 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 12 other ancestors3 generations back: 8 other ancestors4 generations back: 13 other ancestors5 generations back: 5 other ancestors6 generations back: 3 other ancestors 1 generation forward: 32 descendants2 generations forward: 16 descendants, 1 with a Class I recall13 generations forward: 11 descendants4 generations forward: 18 descendants5 generations forward: 16 descendants6 generations forward: 14 descendants7 generations forward: 11 descendants8 generations forward: 5 descendants9 generations forward: 1 descendant K123463 · 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−10−50+5
  1. Root · 13 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 9 generations between
  3. 3 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  4. 2 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
  5. 1 generation backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
  6. This deviceK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014
  7. Descendant · cites it directly · 87 of its ownK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
  8. Descendant · 2 generations on · 70 of its ownK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
  9. Descendant · 3 generations on · 68 of its ownK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
  10. Descendant · 3 generations on · 44 of its ownK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
  11. Descendant · 3 generations on · 33 of its ownK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
Show all 13 generations
  1. Root · 13 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 12 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 11 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 10 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 9 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 8 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 7 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 6 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. 5 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. 4 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. 3 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. 2 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
  13. 1 generation backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
  14. This deviceK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014

Showing 5 of 124 descendants. See all descendants

Descendants cleared per year

2014: 22015: 22016: 72017: 72018: 72019: 42020: 92021: 92022: 122023: 152024: 142025: 192026: 17
2014high 19 (2025) · low 2 (2014)2026

Class I recalls in this family

  • K223095 Senhance Surgical System2 generations on · 2023

Most influential descendants

Showing 5 of 124 · See all
  • K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · cites it directly87descendants
  • K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · 2 generations on70descendants
  • K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · 3 generations on68descendants
  • K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018 · 3 generations on44descendants
  • K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker · 2018 · 3 generations on33descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−12K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−11K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−10K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−9K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−8K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−7K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−6K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
−5K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
−4K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
−3K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
−2K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200…Intuitive Surgical, Inc.20093
−1K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20122
0 (this device)K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.2014—
+1K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20142
+2K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.20161
+3K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016—
+3K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)2018—
+3K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K…Stryker20181

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199130
199210
199320
199420
199520
199770
199820
199930
200150
200230
200310
200440
200520
200620

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201520
201670
201770
201870
201940
202090
202190
2022120
2023151
2024140
2025190
2026170
FIG. 1 — Lineage of K131861, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

1 device in this family has 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 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 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? (3)

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
Kept off the family treeK081137FDA’s K081137 is Intuitive Surgical DA Vinci SI Surgical System: Model IS3000
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Intuitive Surgical, Inc.200925
*K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000
Summary page 1
…General and Plastic Surgery Predicate Device: Intuitive Surgical cia Vinci®Si Surgical System, Model IS3000 (KORI1137, K090993, K 123463) Device Description The cia Vinci Surgical System, Model IS4000 is a software-controlled, electro-mechanical system de…
Intuitive Surgical, Inc.20093
*K123463Intuitive Surgical DA Vinci SI Surgical System Smartpedals
Summary page 1
…General and Plastic Surgery Predicate Device: Intuitive Surgical cia Vinci®Si Surgical System, Model IS3000 (KORI1137, K090993, K 123463) Device Description The cia Vinci Surgical System, Model IS4000 is a software-controlled, electro-mechanical system designed for…
Intuitive Surgical, Inc.20122

Also cleared against K090993: 19 other devices →

What descends from it? (124)

See all 124

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

NumberDeviceApplicantDecidedDescendants
K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.201487
K171294da Vinci X Surgical SystemIntuitive Surgical, Inc.201731
K152578da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc.201625
K161178da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201723
K153276da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201623
K170713da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201722
K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720
K173585da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818
K173842da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc.201818
K172643da Vinci Xi Surgical System; da Vinci X Surgical SystemIntuitive Surgical, Inc.201818

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 2, 2026Class IIZ-2046-2026Nonconforming Material/ComponentDue to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
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…
Dec 19, 2024Class IIZ-0872-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0862-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0866-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0855-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0867-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0856-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0881-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0923-2025Device DesignDue to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Dec 19, 2024Class IIZ-0924-2025Device DesignDue to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Dec 19, 2024Class IIZ-0869-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0874-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0878-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0861-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0868-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0880-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0876-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0847-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0849-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0875-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0865-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0851-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0854-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0857-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0848-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0859-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0860-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Dec 19, 2024Class IIZ-0863-2025Process change controlDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Jun 12, 2023Class IIZ-2059-2023Process controlFenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
Feb 10, 2023Class IIZ-1293-2023Equipment maintenanceDue to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Jan 24, 2023Class IIZ-1262-2023Component change controlPreventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement…
Sep 20, 2022Class IIZ-0133-2023Software Design ChangeInadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated…
Jul 1, 2022Class IIZ-1460-2022Nonconforming Material/ComponentDue to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Sep 21, 2021Class IIZ-0275-2022Labeling Change ControlIncorrect expiration date on its package labeling (shipper box and inner carton label).
Jul 26, 2019Class IIZ-0925-2020Component design/selectionThe firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or…
Jun 17, 2019Class IIZ-0283-2021Equipment maintenanceOne da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal…
Apr 11, 2019Class IIZ-1896-2020Process controlFailure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.
Dec 4, 2018Class IIZ-1105-2020Nonconforming Material/ComponentThis recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console.
Nov 21, 2018Class IIZ-1960-2020Process controlDue to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Aug 15, 2018Class IIZ-3025-2018Use errorMonopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the…
Jul 16, 2018Class IIZ-3254-2018Nonconforming Material/ComponentCertain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
May 17, 2018Class IIZ-2835-2018Use errorAn Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and…
Jun 1, 2017Class IIZ-2630-2017Process controlda Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
Oct 5, 2016Class IIZ-0315-2017Software designIntuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in unexpected master movement and potential instrument tip movement under certain circumstances
Mar 25, 2016Class IIZ-1568-2016Software designPotential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.
Mar 16, 2016Class IIZ-1377-2016Device DesignIntuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic…
Feb 16, 2016Class IIZ-1191-2016Other
Nov 23, 2015Class IIZ-0653-2016Device DesignThis correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs…
Nov 23, 2015Class IIZ-0652-2016Device DesignThis correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm Endoscopes in combination with the da Vinci 8 mm and 12 mm cannulae, cannula reducers, and monopolar energy instruments. It informs…

The 5 latest of 50 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.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
  • 13 of the 54 ancestors have a recall of any class.
  • Of its descendants, K141077 (Intuitive Surgical, Inc., 2014) has gone furthest, with 87 descendants of its own.
  • 19 other devices also cite its predicate K090993.

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. 2014, 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 Endloscopic Instrument Control System (da Vinci Surgical System, Model lS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic dissectors, scissors, scalpels, forcepsipick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp…

Read the full statement (146 words)

The Intuitive Surgical Endloscopic Instrument Control System (da Vinci Surgical System, Model lS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endloscopic dissectors, scissors, scalpels, forcepsipick-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, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotorny procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularination. The system is indicated for adult and pediatric 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.

Indications for use as stated in the FDA summary.

Also cleared against K090993

19 other devices cite the same predicate.

  • K223080da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)Intuitive Surgical, Inc. · 2022
  • K211784da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc. · 2021
  • K202834da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)Intuitive Surgical, Inc. · 2020
  • K183086da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc. · 2020
  • K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc. · 20194 recalls
  • K182140da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018

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/K131861 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131861: DA Vinci Surgical System, Endowrist Instruments and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131861

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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