510(k) · Cleared
ClearedIntuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170
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 May 5, 2004 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) and 5 other predicates after a 23-day review. Its family tree reaches back 4 generations to 1994. 1 of the 244 devices in its family, counting itself, has a Class I recall. 229 later devices descend from it.
- Decided
- May 5, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K930667 (1994). 14 ancestors in all, the oldest K914190 (1992). 229 later devices descend from it, 3 citing it directly. 1 of the 244 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 3 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 2 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 1 generation backK013416 Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002
- This deviceK040948 Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model…Intuitive Surgical, Inc. · 2004
- Descendant · cites it directly · 228 of its ownK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- Descendant · 2 generations on · 224 of its ownK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 211 of its ownK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 155 of its ownK060391 Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 154 of its ownK061260 Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 &…Intuitive Surgical, Inc. · 2006 · Recalled
Showing 5 of 229 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 229 · See all- K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · cites it directly228descendants
- K063220DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · 2 generations on224descendants
- K081137Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · 3 generations on211descendants
- K060391Intuitive Surgical Endowrist Stabilizer, Model 420182Intuitive Surgical, Inc. · 2006 · 2 generations on155descendants
- K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc. · 2006 · 2 generations on154descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −3 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −2 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −1 | K013416 | Intuitive Surgical Endowrist Endoscopic Instrument Family | Intuitive Surgical, Inc. | 2002 | — |
| 0 (this device) | K040948 | Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170 | Intuitive Surgical, Inc. | 2004 | — |
| +1 | 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 |
| +3 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| +2 | K060391 | Intuitive Surgical Endowrist Stabilizer, Model 420182 | Intuitive Surgical, Inc. | 2006 | 1 |
| +2 | K061260 | Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214 | Intuitive Surgical, Inc. | 2006 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 9 | 0 |
| 2015 | 4 | 0 |
| 2016 | 9 | 0 |
| 2017 | 14 | 0 |
| 2018 | 16 | 0 |
| 2019 | 9 | 0 |
| 2020 | 17 | 0 |
| 2021 | 16 | 0 |
| 2022 | 18 | 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? (6)
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 |
|---|---|---|---|
| * | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Summary page 1…ndoscopic Instrument Control System and Intuitive Devices Surgical®Endoscopic Instruments and accessories (legally marketed under K990144 / K002489 / K01 1002 / K013416 / K021036/ K022574) Device This special 510(k) is bein… | 2000 |
| * | K002489 | Intuitive Surgical DA Vinci Endoscopic Control SystemSummary page 1…Instrument Control System and Intuitive Devices Surgical®Endoscopic Instruments and accessories (legally marketed under K990144 / K002489 / K01 1002 / K013416 / K021036/ K022574) Device This special 510(k) is being submitte… | 2001 |
| * | K011002 | Intuitive Surgical DA Vinci Surgical System, Model Isi 1000Summary page 1…Control System and Intuitive Devices Surgical®Endoscopic Instruments and accessories (legally marketed under K990144 / K002489 / K01 1002 / K013416 / K021036/ K022574) Device This special 510(k) is being submitted for a mod… | 2001 |
| * | K013416 | Intuitive Surgical Endowrist Endoscopic Instrument FamilySummary page 1…stem and Intuitive Devices Surgical®Endoscopic Instruments and accessories (legally marketed under K990144 / K002489 / K01 1002 / K013416 / K021036/ K022574) Device This special 510(k) is being submitted for a modification… | 2002 |
| * | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000Summary page 1…ntuitive Devices Surgical®Endoscopic Instruments and accessories (legally marketed under K990144 / K002489 / K01 1002 / K013416 / K021036/ K022574) Device This special 510(k) is being submitted for a modification of Intuiti… | 2002 |
| * | K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Summary page 1…Surgical®Endoscopic Instruments and accessories (legally marketed under K990144 / K002489 / K01 1002 / K013416 / K021036/ K022574) Device This special 510(k) is being submitted for a modification of Intuitive Description Surgic… | 2002 |
What descends from it? (229)
See all 2293 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- 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 10 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K050802 (Intuitive Surgical, Inc., 2005) has gone furthest, with 228 descendants of its own.
- 20 other devices also cite its predicate K990144.
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 sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting…
Read the full statement (134 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 sharp endoscopic dissectors, scissors, scalpels, 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 and suturing during general laparoscopic surgical procedures, general non-cardiovascular thoracoscopic surgical procedures, and thoracoscopically-assisted cardiotomy procedures. 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.
Intuitive Surgical®Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040948 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040948: Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040948
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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