510(k) Report

510(k) · Cleared

Cleared

Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000

K043153510(k) SpecialCleared Dec 15, 200430-day reviewClass II21 CFR 876.1500

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 15, 2004 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 8 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1994. 1 of the 278 devices in its family, counting itself, has a Class I recall. 251 later devices descend from it.

Decided
Dec 15, 2004
Review
30 days
Class
Class II
Product code
NAY
Recalls
None
Predicates
9

Its longest line of descent runs back 5 generations to K930667 (1994). 26 ancestors in all, the oldest K811390 (1981). 251 later devices descend from it, 7 citing it directly. 1 of the 278 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2002: 3 other ancestors2001: 3 other ancestors1998: 1 other ancestor1997: 4 other ancestors1993: 1 other ancestor1995: 2 other ancestors1994: 2 other ancestors1992: 1 other ancestor1988: 1 other ancestor1981: 1 other ancestor1991: 1 other ancestor2009: 3 descendants cleared2005: 4 descendants cleared2014: 11 descendants cleared2008: 6 descendants cleared2011: 5 descendants cleared2006: 3 descendants cleared2018: 18 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2017: 15 descendants cleared2022: 18 descendants cleared2013: 6 descendants cleared2012: 4 descendants cleared2019: 11 descendants cleared2016: 11 descendants cleared2020: 19 descendants cleared2021: 17 descendants cleared2015: 5 descendants cleared2026: 23 descendants cleared2023: 19 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 · recalledK040237 · Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments · Intuitive Surgical, Inc. · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 5 other ancestors3 generations back: 7 other ancestors4 generations back: 3 other ancestors 1 generation forward: 7 descendants2 generations forward: 41 descendants3 generations forward: 37 descendants, 1 with a Class I recall14 generations forward: 29 descendants5 generations forward: 24 descendants6 generations forward: 33 descendants7 generations forward: 27 descendants8 generations forward: 24 descendants9 generations forward: 19 descendants10 generations forward: 9 descendants11 generations forward: 1 descendant K040237 · 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−50+5+10
  1. Root · 5 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 4 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 3 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 2 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 1 generation backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. This deviceK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. Descendant · cites it directly · 231 of its ownK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. Descendant · cites it directly · 230 of its ownK050369 Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · Recalled
  9. Descendant · cites it directly · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  10. Descendant · cites it directly · 228 of its ownK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  11. Descendant · 2 generations on · 224 of its ownK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled

Showing 5 of 251 descendants. See all descendants

Descendants cleared per year

2005: 42006: 32008: 62009: 32011: 52012: 42013: 62014: 112015: 52016: 112017: 152018: 182019: 112020: 192021: 172022: 182023: 192024: 222025: 312026: 23
2005high 31 (2025) · low 0 (2007)2026

Class I recalls in this family

  • K223095 Senhance Surgical System3 generations on · 2023

Most influential descendants

Showing 5 of 251 · See all
  • K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc. · 2005 · cites it directly231descendants
  • K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · cites it directly230descendants
  • K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · cites it directly229descendants
  • K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · cites it directly228descendants
  • K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · 2 generations on224descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−4K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−3K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−2K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−1K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
0 (this device)K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
+1K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
+1K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc.200551
+1K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005—
+1K050802Modification 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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199110
199210
199310
199420
199520
199740
199810
200130
200230
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200540
200630
200860
200930
201150
201240
201360
2014110
201550
2016110
2017150
2018180
2019110
2020190
2021170
2022180
2023191
2024220
2025310
2026230
FIG. 1 — Lineage of K043153, 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? (9)

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
…ents and Accessories Predicate Intuitive Surgical® da Vinci® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237); Guidant Microwave…
Intuitive Surgical, Inc.20003
*K002489Intuitive Surgical DA Vinci Endoscopic Control System
Summary page 1
…ccessories Predicate Intuitive Surgical® da Vinci® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237); Guidant Microwave Ablation…
Intuitive Surgical, Inc.2001—
*K011002Intuitive Surgical DA Vinci Surgical System, Model Isi 1000
Summary page 1
…Predicate Intuitive Surgical® da Vinci® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237); Guidant Microwave Ablation System and…
Intuitive Surgical, Inc.2001—
*K013416Intuitive Surgical Endowrist Endoscopic Instrument Family
Summary page 1
…ve Surgical® da Vinci® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237); Guidant Microwave Ablation System and Flex 10 Accessory (legally markete…
Intuitive Surgical, Inc.2002—
*K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000
Summary page 1
…l® da Vinci® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237); Guidant Microwave Ablation System and Flex 10 Accessory (legally marketed under…
Intuitive Surgical, Inc.200218
*K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…
Summary page 1
…i® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237); Guidant Microwave Ablation System and Flex 10 Accessory (legally marketed under…
Intuitive Surgical, Inc.2002—
*K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…
Summary page 1
…l System and Endoscopic Devices Instruments (legally marketed under K990144 / K002489 / K011002 / K013416 / K021036 / K022574 / K040237); Guidant Microwave Ablation System and Flex 10 Accessory (legally marketed under…
Intuitive Surgical, Inc.2004—
*K013946Flex 10 Accessory for the Afx Microwave Ablation System
Summary page 1
…K013416 / K021036 / K022574 / K040237); Guidant Microwave Ablation System and Flex 10 Accessory (legally marketed under K013946 / K041340) Device This special 510(k) is being submitted for a minor labeling change I Description…
Afx, Inc.2002—
*K041340Guidant Microwave Ablation System
Summary page 1
…K021036 / K022574 / K040237); Guidant Microwave Ablation System and Flex 10 Accessory (legally marketed under K013946 / K041340) Device This special 510(k) is being submitted for a minor labeling change I Description clarific…
Guidant Corporation, Cardiac Surgery2004—

Also cleared against K990144: 20 other devices →

What descends from it? (251)

See all 251

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

NumberDeviceApplicantDecidedDescendants
K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc.2005231
K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc.2005230
K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005229
K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005228
K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.2009153
K072629Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc.200816
K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143

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

No FDA recall names this device.

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 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
  • 3 of the 26 ancestors have a recall of any class.
  • Of its descendants, K050005 (Intuitive Surgical, Inc., 2005) has gone furthest, with 231 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.

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 SurgicarEndoscopic Instrument Control System (hereinafter referred to as the " da Vincif System") is intended to 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, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting…

Read the full statement (132 words)

The Intuitive SurgicarEndoscopic Instrument Control System (hereinafter referred to as the " da Vincif System") is intended to 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, 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 general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. 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 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
  • K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc. · 20093 recalls
  • 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

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/K043153 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043153: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 & IS1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043153

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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