510(k) · Cleared
Recalled · Class II · 2018Intuitive Surgical DA Vinci SI Surgical System: Model IS3000
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 Feb 18, 2009 as substantially equivalent to K050369 (Intuitive Surgical, Inc., 2005) and 1 other predicate after a 303-day review. Its family tree reaches back 10 generations to 1994. 1 of the 256 devices in its family, counting itself, has a Class I recall. 211 later devices descend from it. It has been recalled 25 times.
- Decided
- Feb 18, 2009
- Review
- 303 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 25
- Predicates
- 2
Its longest line of descent runs back 10 generations to K930667 (1994). 44 ancestors in all, the oldest K811390 (1981). 211 later devices descend from it, 29 citing it directly. 1 of the 256 devices in this family, counting this one, has a Class I recall.
- 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 deviceK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009
- Descendant · cites it directly · 153 of its ownK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- Descendant · cites it directly · 148 of its ownK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 124 of its ownK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- Descendant · cites it directly · 104 of its ownK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 103 of its ownK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013
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 deviceK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009
Showing 5 of 211 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 211 · See all- K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc. · 2009 · cites it directly153descendants
- K123463Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · cites it directly148descendants
- K131861DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · 2 generations on124descendants
- K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · cites it directly104descendants
- K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013 · 2 generations on103descendants
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) | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | — |
| +1 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| +1 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| +2 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| +1 | K101077 | DA Vinci Fluorescence Imaging Vision System, Model FF 100 | Intuitive Surgical, Inc. | 2011 | 2 |
| +2 | K124031 | DA Vinci Fluorescence Imaging Vision System | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 9 | 0 |
| 2017 | 14 | 0 |
| 2018 | 16 | 0 |
| 2019 | 8 | 0 |
| 2020 | 15 | 0 |
| 2021 | 16 | 0 |
| 2022 | 16 | 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? (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 2…Manufacturer Substantially equivalent device 510(k) Intuitive Surgical, Inc. da Vinci S Endoscopic Instrument K050369 Sunnyvale, CA Control System (Model IS2000, Vl.1), K063220 E… | 2005 |
| * | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000Summary page 2…Intuitive Surgical, Inc. da Vinci S Endoscopic Instrument K050369 Sunnyvale, CA Control System (Model IS2000, Vl.1), K063220 Endoscopic instruments and accessories De… | 2006 |
What descends from it? (211)
See all 21129 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000 | 2009 | 153 |
| K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | 2012 | 148 |
| K101077 | DA Vinci Fluorescence Imaging Vision System, Model FF 100 | 2011 | 104 |
| K112208 | Intutive Surgical DA Vinci Single Site Instruments and Accessories | 2011 | 43 |
| K122532 | DA Vinci Single-Site Instruments and Accessories | 2013 | 39 |
| K152578 | da Vinci Surgical System, Model IS4000 | 2016 | 25 |
| K161178 | da Vinci Xi Surgical System | 2017 | 23 |
| K153276 | da Vinci Xi Surgical System | 2016 | 23 |
| K170713 | da Vinci Xi Surgical System | 2017 | 22 |
| K131962 | DA Vinci SP Surgical System, Endowrist SP Instruments, and Accessories | 2014 | 22 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2018 | Class II | Z-3254-2018 | Nonconforming Material/Component | Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use. |
| Mar 16, 2016 | Class II | Z-1377-2016 | Device Design | Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic… |
| Feb 16, 2016 | Class II | Z-1191-2016 | Other | |
| Dec 5, 2014 | Class II | Z-0940-2015 | Device Design | Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening. |
| May 21, 2014 | Class II | Z-1971-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1967-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1975-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1966-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1968-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1964-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1974-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1969-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1972-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1973-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1970-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| May 21, 2014 | Class II | Z-1965-2014 | Device Design | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release… |
| Nov 11, 2013 | Class II | Z-0436-2014 | Device Design | Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then… |
| Oct 21, 2013 | Class III | Z-0146-2014 | Nonconforming Material/Component | Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors. |
| Jun 8, 2013 | Class II | Z-1686-2013 | Software design | Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. |
| Jun 8, 2013 | Class II | Z-1687-2013 | Software design | Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. |
| Mar 15, 2013 | Class II | Z-1110-2013 | Nonconforming Material/Component | Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation. |
| Apr 27, 2012 | Class II | Z-1994-2014 | Device Design | Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging. |
| Feb 6, 2012 | Not classified | Z-1202-2012 | Device Design | The holding brake, a component of the da Vinci S Surgical System, may allow passive uncontrolled motion due to gravity during specific power-off conditions. |
| Oct 17, 2011 | Class II | Z-0088-2014 | Use error | Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount. |
| Nov 30, 12 | Class II | Z-0139-2014 | Device Design | Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems. |
The 5 latest of 25 recalls; the web page lists all.
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 15 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, K090993 (Intuitive Surgical, Inc., 2009) has gone furthest, with 153 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. 2009, 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 Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of…
Read the full statement (155 words)
The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical® da Vinci Si Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, 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, 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, general cardiovascular and non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy 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/K081137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081137
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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