510(k) · Cleared
ClearedIntuitive Surgical DA Vinci Endoscopic Instrument Control 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 Jul 7, 2004 as substantially equivalent to K022574 (Intuitive Surgical, Inc., 2002) and 5 other predicates after a 159-day review. Its family tree reaches back 4 generations to 1994. 1 of the 272 devices in its family, counting itself, has a Class I recall. 258 later devices descend from it.
- Decided
- Jul 7, 2004
- Review
- 159 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K930667 (1994). 13 ancestors in all, the oldest K914190 (1992). 258 later devices descend from it, 12 citing it directly. 1 of the 272 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 3 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 2 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 1 generation backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- This deviceK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- Descendant · cites it directly · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- Descendant · cites it directly · 235 of its ownK042855 Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004
- Descendant · cites it directly · 231 of its ownK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- Descendant · cites it directly · 230 of its ownK050369 Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · Recalled
- Descendant · cites it directly · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
Showing 5 of 258 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 258 · See all- K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · cites it directly251descendants
- K042855Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004 · cites it directly235descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −3 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −2 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −1 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| 0 (this device) | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| +1 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| +1 | K042855 | Intuitive Surgical Harmonic Curved Shears Instrument | Intuitive Surgical, Inc. | 2004 | — |
| +1 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| +1 | K050369 | Intuitive Surgical DA Vinci Surgical System, Model IS2000 | Intuitive Surgical, Inc. | 2005 | 51 |
| +1 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 6 | 0 |
| 2016 | 11 | 0 |
| 2017 | 15 | 0 |
| 2018 | 18 | 0 |
| 2019 | 12 | 0 |
| 2020 | 19 | 0 |
| 2021 | 17 | 0 |
| 2022 | 18 | 0 |
| 2023 | 19 | 1 |
| 2024 | 22 | 0 |
| 2025 | 31 | 0 |
| 2026 | 23 | 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? (6)
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 |
|---|---|---|---|
| * | K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Summary page 1…: Substantial equivalence data for the Intuitive Surgical® da VinciTM Surgical System and Endoscopic Instruments were provided in the original pre-market notifications (K022574, K021036, K01 1002, K002489, K990144, K965001). Device Description: The working ends and elements of the Intuitive Surgical® da… | 2002 |
| * | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000Summary page 1…ntial equivalence data for the Intuitive Surgical® da VinciTM Surgical System and Endoscopic Instruments were provided in the original pre-market notifications (K022574, K021036, K01 1002, K002489, K990144, K965001). Device Description: The working ends and elements of the Intuitive Surgical® da Vinc iTM… | 2002 |
| * | K011002 | Intuitive Surgical DA Vinci Surgical System, Model Isi 1000Summary page 1…ivalence data for the Intuitive Surgical® da VinciTM Surgical System and Endoscopic Instruments were provided in the original pre-market notifications (K022574, K021036, K01 1002, K002489, K990144, K965001). Device Description: The working ends and elements of the Intuitive Surgical® da Vinc iTM Surgical… | 2001 |
| * | K002489 | Intuitive Surgical DA Vinci Endoscopic Control SystemSummary page 1…ata for the Intuitive Surgical® da VinciTM Surgical System and Endoscopic Instruments were provided in the original pre-market notifications (K022574, K021036, K01 1002, K002489, K990144, K965001). Device Description: The working ends and elements of the Intuitive Surgical® da Vinc iTM Surgical System, E… | 2001 |
| * | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Summary page 1…he Intuitive Surgical® da VinciTM Surgical System and Endoscopic Instruments were provided in the original pre-market notifications (K022574, K021036, K01 1002, K002489, K990144, K965001). Device Description: The working ends and elements of the Intuitive Surgical® da Vinc iTM Surgical System, Endoscopic… | 2000 |
| * | K965001 | Intuitive Surgical Monarch Laparoscopic ManipulatorSummary page 1…ive Surgical® da VinciTM Surgical System and Endoscopic Instruments were provided in the original pre-market notifications (K022574, K021036, K01 1002, K002489, K990144, K965001). Device Description: The working ends and elements of the Intuitive Surgical® da Vinc iTM Surgical System, Endoscopic Instrume… | 1997 |
What descends from it? (258)
See all 25812 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &… | 2004 | 251 |
| K042855 | Intuitive Surgical Harmonic Curved Shears Instrument | 2004 | 235 |
| K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model… | 2005 | 231 |
| K050369 | Intuitive Surgical DA Vinci Surgical System, Model IS2000 | 2005 | 230 |
| K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | 2005 | 229 |
| K043288 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | 2005 | 229 |
| 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 |
| K080291 | Intuitive Surgical DA Vinci Endoscopic Instruments and Control System and Endowrist… | 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 10 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K043153 (Intuitive Surgical, Inc., 2004) has gone furthest, with 251 descendants of its own.
- 12 other devices also cite its predicate K022574.
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 (hereinafter referred to as the" da Vincio 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 (122 words)
The Intuitive Surgical®Endoscopic Instrument Control System (hereinafter referred to as the" da Vincio 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 and suturing 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.
https://510kreport.com/device/K040237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040237: Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040237
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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