510(k) · Cleared
ClearedIntuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite, Model IS2000
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 Apr 8, 2011 as substantially equivalent to K081207 (Intuitive Surgical, Inc., 2008) after a 305-day review. Its family tree reaches back 11 generations to 1994. 6 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 305 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K930667 (1994). 45 ancestors in all, the oldest K811390 (1981). 6 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 7 generations between
- 3 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 2 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 1 generation backK081207 Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA…Intuitive Surgical, Inc. · 2008
- This deviceK101581 Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect…Intuitive Surgical, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK123329 DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK210478 8mm Monopolar Curved ScissorsIconocare Health · 2022
- Descendant · 2 generations on · 0 of its ownK173415 EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK170641 da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK123840 Connect for DA Vinci Surgical System (S)Intuitive Surgical, Inc. · 2013
Show all 11 generations
- Root · 11 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 10 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 9 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 8 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 7 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 6 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 5 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 4 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 3 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 2 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 1 generation backK081207 Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA…Intuitive Surgical, Inc. · 2008
- This deviceK101581 Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect…Intuitive Surgical, Inc. · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014 · cites it directly3descendants
- K2104788mm Monopolar Curved ScissorsIconocare Health · 2022 · 2 generations on0descendants
- K173415EndoWrist 5mm Thoracic GrasperIntuitive Surgical, Inc. · 2018 · 2 generations on0descendants
- K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc. · 2017 · 2 generations on0descendants
- K123840Connect for DA Vinci Surgical System (S)Intuitive Surgical, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −10 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −9 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −8 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −7 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −6 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −5 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −4 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −3 | 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 |
| −1 | K081207 | Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci… | Intuitive Surgical, Inc. | 2008 | — |
| 0 (this device) | K101581 | Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci… | Intuitive Surgical, Inc. | 2011 | — |
| +1 | K123329 | DA Vinvi Surgical System | Intuitive Surgical, Inc. | 2014 | — |
| +2 | K210478 | 8mm Monopolar Curved Scissors | Iconocare Health | 2022 | — |
| +2 | K173415 | EndoWrist 5mm Thoracic Grasper | Intuitive Surgical, Inc. | 2018 | — |
| +2 | K170641 | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes | Intuitive Surgical, Inc. | 2017 | — |
| +1 | K123840 | Connect for DA Vinci Surgical System (S) | Intuitive Surgical, Inc. | 2013 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K081207 | Intuitive Surgical DA Vinci S Surgical System, Model IS2000, with DA Vinci Connect and…Summary page 1…on: System, Surgical, Computer Controlled Instrument 21 CFR 876. 1500) Predicate Device: K081 207: Intuitive Surgicat' do Vincie S' Surgical System, Model 1S2000, with do Vinci… | 2008 |
What descends from it? (6)
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 17 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 45 ancestors have a recall of any class.
- Of its descendants, K123329 (Intuitive Surgical, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K081207.
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. 2011, 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 doa Vinci Wireless Connectivity Option is intended to provide a suitable alternative for the wired Ethernet connection between the do Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure. The Intuitive Surgical Endloscopic Instrument Control System (1S2000 do Vinci S Surgical System with doi Vinci Connecft do Vinci OnSite) Is intended to assist In the accurate control of Intuitive Surgical Endoscopic Instruments including…
Read the full statement (205 words)
The doa Vinci Wireless Connectivity Option is intended to provide a suitable alternative for the wired Ethernet connection between the do Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure.
The Intuitive Surgical Endloscopic Instrument Control System (1S2000 do Vinci S Surgical System with doi Vinci Connecft do Vinci OnSite) Is intended to assist In the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blurt and sharp endoscopic dissectors, scissors, scaipels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endloscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories during urologic surgical procedures, general laparoscopic surgical procedures, gynecological laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures, and thoracoscopicolly assisted cardlotomy procedures, The system Is indicated for adult and pediatric use. 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/K101581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101581: Intuitive Surgical DA Vinci S Surgical System with DA Vinci Connect & DA Vinci Onsite, Model IS2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101581
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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