510(k) · Cleared
ClearedIntuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and Onsite
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 Dec 19, 2008 as substantially equivalent to K050369 (Intuitive Surgical, Inc., 2005) and 1 other predicate after a 234-day review. Its family tree reaches back 10 generations to 1994. 7 later devices descend from it.
- Decided
- Dec 19, 2008
- Review
- 234 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K930667 (1994). 44 ancestors in all, the oldest K811390 (1981). 7 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 6 generations between
- 3 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 2 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 1 generation backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- This deviceK081207 Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA…Intuitive Surgical, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK101581 Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect…Intuitive Surgical, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK123329 DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK210478 8mm Monopolar Curved ScissorsIconocare Health · 2022
- Descendant · 3 generations on · 0 of its ownK173415 EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK170641 da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017
Show all 10 generations
- Root · 10 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 9 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 8 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 7 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 6 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 5 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 4 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 3 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 2 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 1 generation backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- This deviceK081207 Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA…Intuitive Surgical, Inc. · 2008
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K101581Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite…Intuitive Surgical, Inc. · 2011 · cites it directly6descendants
- K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014 · 2 generations on3descendants
- K2104788mm Monopolar Curved ScissorsIconocare Health · 2022 · 3 generations on0descendants
- K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc. · 2018 · 3 generations on0descendants
- K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −9 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −8 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −7 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −6 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −5 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −4 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −3 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −2 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −1 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| 0 (this device) | K081207 | Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci… | Intuitive Surgical, Inc. | 2008 | — |
| +1 | K101581 | Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci… | Intuitive Surgical, Inc. | 2011 | — |
| +2 | K123329 | DA Vinvi Surgical System | Intuitive Surgical, Inc. | 2014 | — |
| +3 | K210478 | 8mm Monopolar Curved Scissors | Iconocare Health | 2022 | — |
| +3 | K173415 | EndoWrist 5mm Thoracic Grasper | Intuitive Surgical, Inc. | 2018 | — |
| +3 | K170641 | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes | Intuitive Surgical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 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.
Planning a device in NAY? 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? (2)
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 |
|---|---|---|---|
| * | K050369 | Intuitive Surgical DA Vinci Surgical System, Model IS2000Summary page 1…ces Intuitive Surgical da Vinci S Surgical System (Model IS2000) with Endoscopic and Endo Wrist Instruments (legally marketed under K050369 and K063220). Device The da Vinci S Surgical System, Model IS2000 with da Vinci… | 2005 |
| * | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000Summary page 1…i S Surgical System (Model IS2000) with Endoscopic and Endo Wrist Instruments (legally marketed under K050369 and K063220). Device The da Vinci S Surgical System, Model IS2000 with da Vinci Connect and Description… | 2006 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 44 ancestors have a recall of any class.
- Of its descendants, K101581 (Intuitive Surgical, Inc., 2011) has gone furthest, with 6 descendants of its own.
- 19 other devices also cite its predicate K050369.
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. 2008, this device’s year, is highlighted.
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 da Vinci Connect is an accessory to the da Vinci S Surgical System and is intended for use by trained Surgical proctors to communicate and to provide surgical advice to the operating surgeon when using the da Vinci S Surgical System, Model IS2000. In addition, the Remote Proctor Interface can be used to view surgical procedures related to the use of the da Vinci S Surgical System, Model IS2000.
The da Vinci OnSite is an accessory to the da Vinci S Surgical System and is intended for use by trained Intuitive Surgical Customer Service personnel to obtain da Vinci S Surgical System information for the purpose of diagnosing faults with the da Vinci S Surgical System, Model IS2000.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081207 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081207: Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and Onsite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081207
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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