510(k) · Cleared
ClearedModification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · NAY System, Surgical, Computer Controlled Instrument
Cleared on Mar 3, 2005 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 7 other predicates after a 94-day review. Its family tree reaches back 6 generations to 1994. 1 of the 251 devices in its family, counting itself, has a Class I recall. 229 later devices descend from it.
- Decided
- Mar 3, 2005
- Review
- 94 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 6 generations to K930667 (1994). 21 ancestors in all, the oldest K914190 (1992). 229 later devices descend from it, 5 citing it directly. 1 of the 251 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 5 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 4 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 3 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 2 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 1 generation backK042855 Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004
- This deviceK043288 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- Descendant · cites it directly · 228 of its ownK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- Descendant · 2 generations on · 224 of its ownK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 211 of its ownK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 155 of its ownK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
- 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
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 · 2 generations on224descendants
- K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · 3 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −5 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −4 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −3 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −2 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −1 | K042855 | Intuitive Surgical Harmonic Curved Shears Instrument | Intuitive Surgical, Inc. | 2004 | — |
| 0 (this device) | K043288 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| +1 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| +2 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| +3 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| +2 | K060391 | Intuitive Surgical Endowrist Stabilizer, Model 420182 | Intuitive Surgical, Inc. | 2006 | 1 |
| +2 | K061260 | Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214 | Intuitive Surgical, Inc. | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 9 | 0 |
| 2017 | 14 | 0 |
| 2018 | 16 | 0 |
| 2019 | 9 | 0 |
| 2020 | 17 | 0 |
| 2021 | 16 | 0 |
| 2022 | 18 | 0 |
| 2023 | 19 | 1 |
| 2024 | 22 | 0 |
| 2025 | 31 | 0 |
| 2026 | 22 | 0 |
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 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Summary page 1…nstruments and Accessories Predicate Intuitive Surgical® da Vinci® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 I K002489 / K0l11002I K013416 I K021036 / K022574 I K0402371K042855); Device This 5 10(k) i… | 2000 |
| * | K002489 | Intuitive Surgical DA Vinci Endoscopic Control SystemSummary page 1…and Accessories Predicate Intuitive Surgical® da Vinci® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 I K002489 / K0l11002I K013416 I K021036 / K022574 I K0402371K042855); Device This 5 10(k) is being su… | 2001 |
| * | K011002 | Intuitive Surgical DA Vinci Surgical System, Model Isi 1000 | 2001 |
| * | K013416 | Intuitive Surgical Endowrist Endoscopic Instrument FamilySummary page 1…ntuitive Surgical® da Vinci® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 I K002489 / K0l11002I K013416 I K021036 / K022574 I K0402371K042855); Device This 5 10(k) is being submitted for a labeling change I clarificat… | 2002 |
| * | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000Summary page 1…urgical® da Vinci® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 I K002489 / K0l11002I K013416 I K021036 / K022574 I K0402371K042855); Device This 5 10(k) is being submitted for a labeling change I clarification on the… | 2002 |
| * | K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Summary page 1…a Vinci® Surgical System and Endoscopic Devices Instruments (legally marketed under K990144 I K002489 / K0l11002I K013416 I K021036 / K022574 I K0402371K042855); Device This 5 10(k) is being submitted for a labeling change I clarification on the Descripti… | 2002 |
| * | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Summary page 1…urgical System and Endoscopic Devices Instruments (legally marketed under K990144 I K002489 / K0l11002I K013416 I K021036 / K022574 I K0402371K042855); Device This 5 10(k) is being submitted for a labeling change I clarification on the Description… | 2004 |
| * | K042855 | Intuitive Surgical Harmonic Curved Shears InstrumentSummary page 1…System and Endoscopic Devices Instruments (legally marketed under K990144 I K002489 / K0l11002I K013416 I K021036 / K022574 I K0402371K042855); Device This 5 10(k) is being submitted for a labeling change I clarification on the Description da Vi… | 2004 |
What descends from it? (229)
See all 2295 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | 2005 | 228 |
| K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 | 2009 | 153 |
| K123329 | DA Vinvi Surgical System | 2014 | 3 |
| K070947 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist… | 2008 | 0 |
| K072627 | Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments… | 2008 | 0 |
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 2.0 years on median.
- 3 of the 21 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 NAY devicesNAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAY
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NAY
117in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NAY
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NAY
48,456in 2025
MAUDE reports naming product code NAY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 11 | 133 |
| 2008 | 4 | 189 | 3 | 224 |
| 2009 | 3 | 253 | 1 | 380 |
| 2010 | 1 | — | 0 | 623 |
| 2011 | 7 | 191 | 2 | 501 |
| 2012 | 4 | 106 | 1 | 1,552 |
| 2013 | 4 | 144 | 6 | 6,217 |
| 2014 | 9 | 143 | 25 | 6,135 |
| 2015 | 3 | 99 | 3 | 1,722 |
| 2016 | 8 | 197 | 1 | 1,077 |
| 2017 | 16 | 107 | 1 | 1,049 |
| 2018 | 15 | 152 | 2 | 1,074 |
| 2019 | 8 | 73 | 5 | 1,154 |
| 2020 | 9 | 212 | 0 | 1,558 |
| 2021 | 11 | 61 | 3 | 1,997 |
| 2022 | 6 | 57 | 3 | 5,727 |
| 2023 | 5 | 141 | 2 (1) | 10,898 |
| 2024 | 10 | 126 | 40 | 12,872 |
| 2025 | 16 | 117 | 1 | 48,456 |
| 2026 | 7 | 89 | 4 (1) | — |
What is it indicated for?
The Intuitive Surgical®Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgicale Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceis/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection…
Read the full statement (128 words)
The Intuitive Surgical®Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgicale Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceis/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 urologic surgical procedures, 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 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.
https://510kreport.com/device/K043288 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043288: Modification to 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 4, 2026. https://510kreport.com/device/K043288
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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