510(k) · Cleared
Clearedda Vinci Surgical System (IS5000)
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 3, 2024 as substantially equivalent to K232610 (Intuitive Surgical, Inc., 2024) after a 57-day review. Its family tree reaches back 25 generations to 1994. 3 of the 147 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jul 3, 2024
- Review
- 57 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 25 generations to K930667 (1994). 144 ancestors in all, the oldest K811390 (1981). 2 later devices descend from it, 1 citing it directly. 3 of the 147 devices in this family, counting this one, have a Class I recall.
- Root · 25 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 21 generations between
- 3 generations backK211784 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System…Intuitive Surgical, Inc. · 2021
- 2 generations backK223080 da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System…Intuitive Surgical, Inc. · 2022
- 1 generation backK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024 · Recalled
- This deviceK241284 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK243641 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253986 da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc. · 2026
Show all 25 generations
- Root · 25 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 24 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 23 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 22 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 21 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 20 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 19 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 18 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 17 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 16 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 15 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 14 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 13 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 12 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 11 generations backK152578 da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc. · 2016
- 10 generations backK153276 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2016
- 9 generations backK170713 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2017
- 8 generations backK171632 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2017
- 7 generations backK173842 da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018
- 6 generations backK182140 da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018
- 5 generations backK183086 da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc. · 2020
- 4 generations backK202834 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System…Intuitive Surgical, Inc. · 2020
- 3 generations backK211784 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System…Intuitive Surgical, Inc. · 2021
- 2 generations backK223080 da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System…Intuitive Surgical, Inc. · 2022
- 1 generation backK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024 · Recalled
- This deviceK241284 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −24 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −23 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −22 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −21 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −20 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −19 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −18 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −17 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −16 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −15 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −14 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −13 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −12 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −11 | K152578 | da Vinci Surgical System, Model IS4000 | Intuitive Surgical, Inc. | 2016 | — |
| −10 | K153276 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2016 | — |
| −9 | K170713 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2017 | — |
| −8 | K171632 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2017 | — |
| −7 | K173842 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018 | — |
| −6 | K182140 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018 | — |
| −5 | K183086 | da Vinci X and Xi Surgical System | Intuitive Surgical, Inc. | 2020 | — |
| −4 | K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | 2020 | — |
| −3 | K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | 2021 | — |
| −2 | K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) | Intuitive Surgical, Inc. | 2022 | — |
| −1 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with… | Intuitive Surgical, Inc. | 2024 | 6 |
| 0 (this device) | K241284 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024 | — |
| +1 | K243641 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024 | — |
| +2 | K253986 | da Vinci Force Feedback Instruments | Intuitive Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 10 | 0 |
| 1998 | 4 | 0 |
| 1999 | 8 | 0 |
| 2000 | 2 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 1 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 7 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 4 | 1 |
| 2012 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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.
3 devices in this family have 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? (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 |
|---|---|---|---|
| * | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Summary page 4…Y (System, Surgical, Computer Controlled Instrument) Review Panel: General and Plastic Surgery Predicate Devices: da Vinci Force Feedback Instruments (K232610) Device Description: The da Vinci Force Feedback Instruments are 8 mm, multi‐use, endoscopic instruments intended for use with th… | 2024 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243641 | da Vinci Surgical System (IS5000) | 2024 | 1 |
Has anything in its family been recalled? (3 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.
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 5 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 6 generations back · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall
- K014166Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002 · 7 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 38 of the 144 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K243641 (Intuitive Surgical, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K232610.
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. 2024, 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 (da Vinci Surgical System, Model IS5000) shall 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, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection…
Read the full statement (167 words)
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall 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, 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, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.
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.
Contraindication:
Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241284: da Vinci Surgical System (IS5000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241284
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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