510(k) Report

510(k) · Cleared

Cleared

Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments

K050404510(k) TraditionalCleared Apr 21, 200563-day reviewClass II21 CFR 884.1720

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

Intuitive Surgical, Inc. · HET Laparoscope, Gynecologic (And Accessories)

Cleared on Apr 21, 2005 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 11 other predicates after a 63-day review. Its family tree reaches back 7 generations to 1994. 1 of the 268 devices in its family, counting itself, has a Class I recall. 229 later devices descend from it.

Decided
Apr 21, 2005
Review
63 days
Class
Class II
Product code
HET
Recalls
None
Predicates
13

Its longest line of descent runs back 7 generations to K930667 (1994). 38 ancestors in all, the oldest K811390 (1981). 229 later devices descend from it, 7 citing it directly. 1 of the 268 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2004: 2 other ancestors2002: 3 other ancestors2001: 5 other ancestors1999: 2 other ancestors1997: 6 other ancestors1993: 2 other ancestors1998: 2 other ancestors1995: 2 other ancestors1994: 2 other ancestors1992: 1 other ancestor1991: 2 other ancestors1988: 1 other ancestor1981: 1 other ancestor2009: 2 descendants cleared2008: 5 descendants cleared2013: 4 descendants cleared2014: 9 descendants cleared2005: 1 descendant cleared2006: 3 descendants cleared2017: 14 descendants cleared2012: 4 descendants cleared2019: 9 descendants cleared2018: 16 descendants cleared2016: 9 descendants cleared2020: 17 descendants cleared2021: 16 descendants cleared2022: 18 descendants cleared2011: 4 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2015: 4 descendants cleared2026: 22 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 · recalled×3: 3 generations cleared close together, K040237 (2004), K043153 (2004), K050005 (2005) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 6 other ancestors3 generations back: 10 other ancestors4 generations back: 5 other ancestors5 generations back: 3 other ancestors 1 generation forward: 7 descendants2 generations forward: 31 descendants3 generations forward: 38 descendants, 1 with a Class I recall14 generations forward: 27 descendants5 generations forward: 24 descendants6 generations forward: 31 descendants7 generations forward: 25 descendants8 generations forward: 20 descendants9 generations forward: 18 descendants10 generations forward: 7 descendants11 generations forward: 1 descendant K050005 · 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−50+5+10
  1. Root · 7 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 6 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 5 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. 4 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. 3 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. 2 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. 1 generation backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. This deviceK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
  9. Descendant · cites it directly · 228 of its ownK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
  10. Descendant · cites it directly · 224 of its ownK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
  11. Descendant · 2 generations on · 211 of its ownK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
  12. Descendant · 2 generations on · 155 of its ownK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
  13. Descendant · 2 generations on · 154 of its ownK061260 Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 &…Intuitive Surgical, Inc. · 2006 · Recalled

Showing 5 of 229 descendants. See all descendants

Descendants cleared per year

2005: 12006: 32008: 52009: 22011: 42012: 42013: 42014: 92015: 42016: 92017: 142018: 162019: 92020: 172021: 162022: 182023: 192024: 222025: 312026: 22
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 229 · See all
  • 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 · cites it directly224descendants
  • K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · 2 generations on211descendants
  • K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · 2 generations on155descendants
  • K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc. · 2006 · 2 generations on154descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−6K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−5K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
−4K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
−3K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
−2K043153Intuitive 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
0 (this device)K050404Intuitive 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—
+1K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.20064
+2K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc.200925
+2K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc.20061
+2K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc.20061

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199120
199210
199320
199420
199520
199760
199820
199920
200150
200230
200420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200630
200850
200920
201140
201240
201340
201490
201540
201690
2017140
2018160
201990
2020170
2021160
2022180
2023191
2024220
2025310
2026220
FIG. 1 — Lineage of K050404, 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 HET device

  1. #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 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? (13)

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
*K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…
Summary page 1
…Control System, Endoscopic Instruments and Accessories Predicate Intuitive Surgical da Vinci Surgical System and Endoscopic [ostruments Devices (legally marketed under K990144 / K002489 / KO1100Z / KOT1281 / KO12833 / KO13416 / K021036 / K022574 / K040237 / KOA091K / K043153 / K042855 / KOS0005). Devic…
Intuitive Surgical, Inc.20003
*K002489Intuitive Surgical DA Vinci Endoscopic Control System
Summary page 1
…ystem, Endoscopic Instruments and Accessories Predicate Intuitive Surgical da Vinci Surgical System and Endoscopic [ostruments Devices (legally marketed under K990144 / K002489 / KO1100Z / KOT1281 / KO12833 / KO13416 / K021036 / K022574 / K040237 / KOA091K / K043153 / K042855 / KOS0005). Device This S10…
Intuitive Surgical, Inc.2001—
*K011002Intuitive Surgical DA Vinci Surgical System, Model Isi 1000Intuitive Surgical, Inc.2001—
*K011281Intuitive Surgical Ultrasonic ShearsIntuitive Surgical, Inc.2001—
*K012833Intuitive Surgical Bipolar ForcepsIntuitive Surgical, Inc.20014
*K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc.2002—
*K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000
Summary page 1
…icate Intuitive Surgical da Vinci Surgical System and Endoscopic [ostruments Devices (legally marketed under K990144 / K002489 / KO1100Z / KOT1281 / KO12833 / KO13416 / K021036 / K022574 / K040237 / KOA091K / K043153 / K042855 / KOS0005). Device This S10(K) is being submitted for an cxpansion of the Indi…
Intuitive Surgical, Inc.200218
*K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…
Summary page 1
…itive Surgical da Vinci Surgical System and Endoscopic [ostruments Devices (legally marketed under K990144 / K002489 / KO1100Z / KOT1281 / KO12833 / KO13416 / K021036 / K022574 / K040237 / KOA091K / K043153 / K042855 / KOS0005). Device This S10(K) is being submitted for an cxpansion of the Indications fo…
Intuitive Surgical, Inc.2002—
*K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…
Summary page 1
…ical da Vinci Surgical System and Endoscopic [ostruments Devices (legally marketed under K990144 / K002489 / KO1100Z / KOT1281 / KO12833 / KO13416 / K021036 / K022574 / K040237 / KOA091K / K043153 / K042855 / KOS0005). Device This S10(K) is being submitted for an cxpansion of the Indications for Descrip…
Intuitive Surgical, Inc.2004—
Kept off the family treeK040918FDA’s K040918 is Wako Lipid Control, Level 1 and Level 2
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Wako Chemicals USA, Inc.20041
*K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…
Summary page 1
…al System and Endoscopic [ostruments Devices (legally marketed under K990144 / K002489 / KO1100Z / KOT1281 / KO12833 / KO13416 / K021036 / K022574 / K040237 / KOA091K / K043153 / K042855 / KOS0005). Device This S10(K) is being submitted for an cxpansion of the Indications for Description Use to include…
Intuitive Surgical, Inc.2004—
*K042855Intuitive Surgical Harmonic Curved Shears Instrument
Summary page 1
…and Endoscopic [ostruments Devices (legally marketed under K990144 / K002489 / KO1100Z / KOT1281 / KO12833 / KO13416 / K021036 / K022574 / K040237 / KOA091K / K043153 / K042855 / KOS0005). Device This S10(K) is being submitted for an cxpansion of the Indications for Description Use to include gynceologi…
Intuitive Surgical, Inc.2004—
*K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc.20052

Also cleared against K990144: 20 other devices →

What descends from it? (229)

See all 229

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

NumberDeviceApplicantDecidedDescendants
K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc.2005228
K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc.2006224
K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc.2009153
K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc.201339
K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc.20143
K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist…Intuitive Surgical, Inc.20080
K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments…Intuitive Surgical, Inc.20080

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 11 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • 5 of the 38 ancestors have a recall of any class.
  • Of its descendants, K050802 (Intuitive Surgical, Inc., 2005) has gone furthest, with 228 descendants of its own.
  • 20 other devices also cite its predicate K990144.

How does its category compare?

All HET devices

HET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HET

2in 2025

2008: 32009: 12010: 12011: 22012: 22013: 22015: 22017: 22018: 12019: 22020: 22021: 42022: 12025: 2
2007high 4 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HET

269in 2021

2008: 176 days median2021: 269 days median
2007high 269 (2021) · low 176 (2008)2026

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

Recalls per year · HET

4in 2023

2008: 42009: 12015: 12022: 12023: 4
2007high 4 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HET

4,513in 2025

2007: 1812008: 3592009: 4032010: 2142011: 4172012: 1,1182013: 1,0352014: 1752015: 1242016: 2052017: 892018: 532019: 442020: 492021: 1322022: 2162023: 8242024: 3,4962025: 4,513
2007high 4,513 (2025) · low 44 (2019)2025

MAUDE reports naming product code HET, 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—0181
200831764359
20091—1403
20101—0214
20112—0417
20122—01,118
20132—01,035
20140—0175
20152—1124
20160—0205
20172—089
20181—053
20192—044
20202—049
202142690132
20221—1216
20230—4824
20240—03,496
20252—04,513
20260—0—

What is it indicated for?

The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during gynecologic laparoscopic 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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 HET

The HET category page

  • K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) Limited · 2025
  • K243821i-CutA.M.I. Agency For Medical Innovations GmbH · 2025
  • K221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) Limited · 2022
  • K210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2021
  • K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp. · 20211 recall

https://510kreport.com/device/K050404 · printed Nov 3, 2026

Cite this page

510(k) Report. “K050404: Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050404

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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