510(k) · Cleared
Recalled · 2007Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System
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 11, 2000 as substantially equivalent to K931340 (Baxter Healthcare Corp, 1993) and 1 other predicate after a 539-day review. Its family tree reaches back 2 generations to 1994. 1 of the 274 devices in its family, counting itself, has a Class I recall. 269 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 11, 2000
- Review
- 539 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930667 (1994). 4 ancestors in all, the oldest K931340 (1993). 269 later devices descend from it, 21 citing it directly. 1 of the 274 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 1 generation backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- This deviceK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000
- Descendant · cites it directly · 260 of its ownK022574 Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc. · 2002
- Descendant · cites it directly · 260 of its ownK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- Descendant · cites it directly · 258 of its ownK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- Descendant · cites it directly · 254 of its ownK013416 Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002
- Descendant · cites it directly · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
Showing 5 of 269 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 269 · See all- K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Intuitive Surgical, Inc. · 2002 · cites it directly260descendants
- K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · cites it directly260descendants
- K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Intuitive Surgical, Inc. · 2004 · cites it directly258descendants
- K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002 · cites it directly254descendants
- K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · cites it directly251descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −1 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| 0 (this device) | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | — |
| +1 | K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic… | Intuitive Surgical, Inc. | 2002 | — |
| +1 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| +1 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| +1 | K013416 | Intuitive Surgical Endowrist Endoscopic Instrument Family | Intuitive Surgical, Inc. | 2002 | — |
| +1 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 8 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 12 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K931340 | Grasp Forceps/Scissors/Needle Holder/DissectorSummary page 1…ollowing predicate devices: 1. Various Class I Exempt and Class II endoscopic electrocautery surgical mstruments including the Baxier Healthcare Endoscopic Instruments (K931340) and the Deknatel Snowden Pencer Diamond Touch™ Brand of Endoscopic Instruments (K960400). 2. The Intuitive Surgical’™ Endoscopi… | 1993 |
| * | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port…Summary page 1…tery surgical mstruments including the Baxier Healthcare Endoscopic Instruments (K931340) and the Deknatel Snowden Pencer Diamond Touch™ Brand of Endoscopic Instruments (K960400). 2. The Intuitive Surgical’™ Endoscopic Instrument Control System and selected instruments (K975001). 510(k) SU… | 1996 |
| Kept off the family tree | K975001 | Intuitive Surgical™ Endoscopic Instrument Control System and selected… Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…atel Snowden Pencer Diamond Touch™ Brand of Endoscopic Instruments (K960400). 2. The Intuitive Surgical’™ Endoscopic Instrument Control System and selected instruments (K975001). 510(k) SUMMARY - Intuitive Surgical, Inc. (Continued) Device Description: The working ends and elements of th… |
What descends from it? (269)
See all 26921 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model… | 2002 | 260 |
| K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | 2002 | 260 |
| K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic… | 2004 | 258 |
| K013416 | Intuitive Surgical Endowrist Endoscopic Instrument Family | 2002 | 254 |
| K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &… | 2004 | 251 |
| K042855 | Intuitive Surgical Harmonic Curved Shears Instrument | 2004 | 235 |
| K012833 | Intuitive Surgical Bipolar Forceps | 2001 | 233 |
| 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 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2007 | Not classified | Z-0152-2008 | Mixed-up of materials/components | Under-Rated Fuses -- The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the… |
| Oct 4, 2007 | Not classified | Z-0151-2008 | Mixed-up of materials/components | Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use… |
| May 3, 2007 | Not classified | Z-1244-2007 | Software design | Under certain circumstances, the product's software may crash and require a manual override or restart before functioning again. In addition, there is an unrelated addendum to the User Manual to clarify an icon not described in the… |
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 6 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K022574 (Intuitive Surgical, Inc., 2002) has gone furthest, with 260 descendants of its own.
- 2 other devices also cite its predicate K931340.
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 Vinci™ System”) is intended to assist in the accurate control of Intuitive Surgical™ endoscopic instruments including: rigid endoscopes, blunt and s endoscopic dissectors, scissors, scalpels, forceps / pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy or…
Read the full statement (105 words)
The Intuitive Surgical™ Endoscopic Instrument Control System (hereinafter referred to as the “da Vinci™ System”) is intended to assist in the accurate control of Intuitive Surgical™ endoscopic instruments including: rigid endoscopes, blunt and s endoscopic dissectors, scissors, scalpels, forceps / pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories during laparoscopic surgical procedures such as cholecystectomy or Nissen fundoplication. It is intended for use by trained physicians in an operating room environment.
Intuitive Surgical™ Endoscopic Instruments including scissors, scalpels. forceps/pick-ups, needle holders, clip appliers, and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990144: Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990144
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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