510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000

K090993510(k) TraditionalCleared Dec 16, 2009253-day reviewClass II21 CFR 876.1500Recalls 3

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 Dec 16, 2009 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 20 other predicates after a 253-day review. Its family tree reaches back 11 generations to 1994. 1 of the 206 devices in its family, counting itself, has a Class I recall. 153 later devices descend from it. It has been recalled 3 times.

Decided
Dec 16, 2009
Review
253 days
Class
Class II
Product code
NAY
Recalls
3
Predicates
21

Its longest line of descent runs back 11 generations to K930667 (1994). 52 ancestors in all, the oldest K811390 (1981). 153 later devices descend from it, 20 citing it directly. 1 of the 206 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 cleared2012: 1 descendant cleared2019: 5 descendants cleared2018: 9 descendants cleared2016: 7 descendants cleared2020: 12 descendants cleared2021: 12 descendants cleared2014: 5 descendants cleared2022: 13 descendants cleared2011: 1 descendant cleared2025: 26 descendants cleared2024: 18 descendants cleared2015: 2 descendants cleared2026: 18 descendants cleared2023: 17 descendants cleared, 1 with a Class I recall1K930667 · 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 12 other ancestors2 generations back: 8 other ancestors3 generations back: 13 other ancestors4 generations back: 5 other ancestors5 generations back: 3 other ancestors 1 generation forward: 20 descendants2 generations forward: 24 descendants, 1 with a Class I recall13 generations forward: 18 descendants4 generations forward: 14 descendants5 generations forward: 21 descendants6 generations forward: 18 descendants7 generations forward: 16 descendants8 generations forward: 15 descendants9 generations forward: 6 descendants10 generations forward: 1 descendant K081137 · 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+10
  1. Root · 11 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 7 generations between
  3. 3 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  4. 2 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  5. 1 generation backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  6. This deviceK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009
  7. Descendant · cites it directly · 148 of its ownK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
  8. Descendant · cites it directly · 124 of its ownK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
  9. Descendant · 2 generations on · 87 of its ownK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
  10. Descendant · 3 generations on · 70 of its ownK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
  11. Descendant · 4 generations on · 68 of its ownK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
Show all 11 generations
  1. Root · 11 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 10 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 9 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 8 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 7 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 6 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 5 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. 4 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. 3 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. 2 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. 1 generation backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. This deviceK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009

Showing 5 of 153 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 52015: 22016: 72017: 72018: 92019: 52020: 122021: 122022: 132023: 172024: 182025: 262026: 18
2011high 26 (2025) · low 0 (2013)2026

Class I recalls in this family

  • K223095 Senhance Surgical System2 generations on · 2023

Most influential descendants

Showing 5 of 153 · See all
  • K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · cites it directly148descendants
  • K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · cites it directly124descendants
  • K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · 2 generations on87descendants
  • K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · 3 generations on70descendants
  • K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · 4 generations on68descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−10K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−9K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−8K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−7K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−6K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
−5K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
−4K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
−3K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc.2005—
−2K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
−1K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
0 (this device)K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200…Intuitive Surgical, Inc.2009—
+1K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.20122
+1K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.201480
+2K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.20142
+3K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.20161
+4K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016—

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
201110
201210
201450
201520
201670
201770
201890
201950
2020120
2021120
2022130
2023171
2024180
2025260
2026180
FIG. 1 — Lineage of K090993, 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.

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? (21)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…
Summary page 1
…Sum/ical da Vinci Surgical Systems (Models IS1200, Devices 1S2000, 1S3000) and EndoWrist Instruments and Accessories (legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K…
Intuitive Surgical, Inc.20003
*K002489Intuitive Surgical DA Vinci Endoscopic Control System
Summary page 1
…da Vinci Surgical Systems (Models IS1200, Devices 1S2000, 1S3000) and EndoWrist Instruments and Accessories (legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K…
Intuitive Surgical, Inc.2001—
*K011002Intuitive Surgical DA Vinci Surgical System, Model Isi 1000
Summary page 1
…urgical Systems (Models IS1200, Devices 1S2000, 1S3000) and EndoWrist Instruments and Accessories (legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K0…
Intuitive Surgical, Inc.2001—
*K011281Intuitive Surgical Ultrasonic Shears
Summary page 1
…tems (Models IS1200, Devices 1S2000, 1S3000) and EndoWrist Instruments and Accessories (legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO0…
Intuitive Surgical, Inc.2001—
*K012833Intuitive Surgical Bipolar Forceps
Summary page 1
…1S2000, 1S3000) and EndoWrist Instruments and Accessories (legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I…
Intuitive Surgical, Inc.20014
*K013416Intuitive Surgical Endowrist Endoscopic Instrument Family
Summary page 1
…1S2000, 1S3000) and EndoWrist Instruments and Accessories (legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I…
Intuitive Surgical, Inc.2002—
*K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000
Summary page 1
…S3000) and EndoWrist Instruments and Accessories (legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K05…
Intuitive Surgical, Inc.200218
*K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…
Summary page 1
…EndoWrist Instruments and Accessories (legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06…
Intuitive Surgical, Inc.2002—
*K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…
Summary page 1
…Instruments and Accessories (legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K0…
Intuitive Surgical, Inc.2004—
*K040948Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170
Summary page 1
…ts and Accessories (legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K061260 I K0…
Intuitive Surgical, Inc.2004—
*K042855Intuitive Surgical Harmonic Curved Shears Instrument
Summary page 1
…(legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K061260 I K063220 I KO0i1137). Device…
Intuitive Surgical, Inc.2004—
*K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…
Summary page 1
…legally marketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K061260 I K063220 I KO0i1137). Device T…
Intuitive Surgical, Inc.2004—
*K043288Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Summary page 1
…rketed under: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K061260 I K063220 I KO0i1137). Device This 510(k)…
Intuitive Surgical, Inc.2005—
*K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…
Summary page 1
…: K990144 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K061260 I K063220 I KO0i1137). Device This 510(k) isbeing su…
Intuitive Surgical, Inc.20052
*K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000
Summary page 1
…4 I K002489 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K061260 I K063220 I KO0i1137). Device This 510(k) isbeing submitted t…
Intuitive Surgical, Inc.200551
*K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Summary page 1
…9 I K01 1002 / K01 1281 I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K061260 I K063220 I KO0i1137). Device This 510(k) isbeing submitted to request…
Intuitive Surgical, Inc.2005—
*K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Summary page 1
…I K012833 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K061260 I K063220 I KO0i1137). Device This 510(k) isbeing submitted to request an expansion of the Descrip…
Intuitive Surgical, Inc.2005—
*K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061
*K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214
Summary page 1
…33 I K013416 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K061260 I K063220 I KO0i1137). Device This 510(k) isbeing submitted to request an expansion of the Description Indications…
Intuitive Surgical, Inc.20061
*K063220DA Vinci S Surgical System-V1.1, Model IS2000
Summary page 1
…16 I K021036 I K022574 I K040237 I K040948 I K042855/I K043153 / K043288/I KO050005I K050369/I K050404/I K050802 I K06039.1 I K061260 I K063220 I KO0i1137). Device This 510(k) isbeing submitted to request an expansion of the Description Indications for Use t…
Intuitive Surgical, Inc.20064
*K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000
Our reading of the summary gave K001137, FDA’s number for Aerotrach Plus Valved Holding Chamber (VHC) (Trudell Medical Int'L). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Intuitive Surgical da Vinci Surgical Systems (Models IS1200, IS2000…”.
Intuitive Surgical, Inc.200925

Also cleared against K990144: 20 other devices →

What descends from it? (153)

See all 153

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

NumberDeviceApplicantDecidedDescendants
K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc.2012148
K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc.2014124
K112263Monopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc.201127
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
K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesIntuitive Surgical, Inc.201920
K171632da Vinci Xi Surgical SystemIntuitive Surgical, Inc.201720
K173585da 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
Jan 24, 2013Class IIZ-1424-2013Labeling False and MisleadingChange to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Oct 13, 2011Class IIZ-1426-2013No Marketing ApplicationPromotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Jul 5, 2011Not classifiedZ-2930-2011Device DesignPotential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement.

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 15 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
  • 11 of the 52 ancestors have a recall of any class.
  • Of its descendants, K123463 (Intuitive Surgical, Inc., 2012) has gone furthest, with 148 descendants of its own.
  • 20 other devices also cite its predicate K990144.

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. 2009, 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 Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 1S2000, IS3000) are intended to assist in the accurate control of Intuitive. Surgical Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears, forceps/pick-ups, needle holders, endloscopic retractors, stabilizers…

Read the full statement (180 words)

The Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 1S2000, IS3000) are intended to assist in the accurate control of Intuitive. Surgical Endoscopic EndoWrist Instruments and Accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic/harmonic shears, forceps/pick-ups, needle holders, endloscopic retractors, stabilizers, 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 ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as Ti and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomny procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended for use 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 K990144

20 other devices cite the same predicate.

  • K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014
  • K1017435MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319Intuitive Surgical, Inc. · 20111 recall
  • K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist Cardiac Probe GrasperIntuitive Surgical, Inc. · 20081 recall
  • K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments and Endowrist IntroducerIntuitive Surgical, Inc. · 2008
  • K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc. · 20061 recall
  • K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 20061 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/K090993 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090993: Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090993

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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