510(k) Report

FDA applicant

Intuitive Surgical, Inc.

Sunnyvale, CA198 decisions1997–2026261 recalls

FDA records 198 decisions for Intuitive Surgical, Inc. (Sunnyvale, CA) from 1997 to 2026: 198 510(k) clearances. Most are in product codes NAY (System, Surgical, Computer Controlled Instrument) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 600 predicates, 551 of them its own earlier devices. 261 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “Intuitive Surgical”.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Intuitive Surgical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

21in 2025

2007: 12008: 72009: 32010: 12011: 82012: 42013: 52014: 132015: 62016: 92017: 162018: 132019: 102020: 92021: 92022: 72023: 72024: 152025: 212026 (partial year): 10
2007high 21 (2025) · low 1 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2026

2007: 112008: 22009: 12011: 72012: 92013: 182014: 482015: 242016: 142017: 192018: 122019: 132020: 32021: 42022: 82023: 42024: 422025: 132026 (partial year): 4, 1 Class I
2007high 48 (2014) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Intuitive Surgical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intuitive Surgical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • NAYSystem, Surgical, Computer Controlled Instrument147decisions
  • GCJLaparoscope, General & Plastic Surgery18decisions
  • EOQBronchoscope (Flexible Or Rigid)11decisions
  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories7decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories6decisions
  • QIHAutomated Radiological Image Processing Software2decisions

Also: LLZ (1), OWN (1), LKF (1), HET (1), NVE (1), GAG (1).

How long do its 510(k) reviews take?

Since 2016, its 125 510(k)s took a median of 95 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 117 days; 71 of its 125 were faster than that.

Whose devices does it build on?

Its devices cite 600 predicates; 551 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 593 times; 551 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 201432cite it
  • K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 200929cite it
  • K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control SystemIntuitive Surgical, Inc. · 200021cite it
  • K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc. · 200920cite it
  • K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 200520cite it
  • K171294da Vinci X Surgical SystemIntuitive Surgical, Inc. · 201716cite it

What has FDA decided for it lately?

  • 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
  • K260695da Vinci Firefly Imaging SystemIntuitive Surgical · 2026
  • K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc. · 2026
  • K253978Universal Seal (5-12 mm)Intuitive Surgical, Inc. · 2026

All 181 as Intuitive Surgical, Inc. →All 17 as Intuitive Surgical →

What has been recalled?

261 recalls linked to its devices; the latest:

  • K232610Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746…Apr 24, 2026Class II
  • K173906Da Vinci ASSY, PSS, SP1098, Part Number: 380601Apr 22, 2026Class II
  • K131861Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System…Apr 2, 2026Class II
  • K211997Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Mar 11, 2026Class I
  • K232610da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number…Dec 30, 2025Class II
  • K202571da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073…Dec 15, 2025Class II

Other applicant names beginning “Intuitive”

FDA records each applicant name separately; these may or may not be the same firm.

Intuitive Imaging Informatics, LLC 3Intuitive Spine, LLC 1Intuitive Surgical Operations, Inc. 1