510(k) · Cleared
Recalled · Class II · 2014Intuitive Surgical DA Vinci Surgical System, Model IS1000
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 Jun 26, 2002 as substantially equivalent to K965001 (Intuitive Surgical, Inc., 1997) and 3 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1994. 1 of the 272 devices in its family, counting itself, has a Class I recall. 260 later devices descend from it. It has been recalled 18 times.
- Decided
- Jun 26, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 18
- Predicates
- 4
Its longest line of descent runs back 3 generations to K930667 (1994). 11 ancestors in all, the oldest K914190 (1992). 260 later devices descend from it, 15 citing it directly. 1 of the 272 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 2 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 1 generation backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- This deviceK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002
- 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 · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- Descendant · cites it directly · 235 of its ownK042855 Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004
- Descendant · cites it directly · 231 of its ownK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- Descendant · cites it directly · 230 of its ownK050369 Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · Recalled
Showing 5 of 260 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 260 · See all- K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Intuitive Surgical, Inc. · 2004 · cites it directly258descendants
- K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · cites it directly251descendants
- K042855Intuitive Surgical Harmonic Curved Shears InstrumentIntuitive Surgical, Inc. · 2004 · cites it directly235descendants
- K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc. · 2005 · cites it directly231descendants
- K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · cites it directly230descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −2 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −1 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| 0 (this device) | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | — |
| +1 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| +1 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| +1 | K042855 | Intuitive Surgical Harmonic Curved Shears Instrument | Intuitive Surgical, Inc. | 2004 | — |
| +1 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| +1 | K050369 | Intuitive Surgical DA Vinci Surgical System, Model IS2000 | Intuitive Surgical, Inc. | 2005 | 51 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 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? (4)
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 |
|---|---|---|---|
| * | K965001 | Intuitive Surgical Monarch Laparoscopic ManipulatorSummary page 1…Gynecologic Laparoscope and Accessories (21 CFR 884.1720) Predicate da VinciTMSurgical System Devices (legally marketed under K965001/K990144/K002489/KO11002) Device The Intuitive Surgical@Endoscopic Instrument Control System Description… | 1997 |
| * | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Summary page 1…Gynecologic Laparoscope and Accessories (21 CFR 884.1720) Predicate da VinciTMSurgical System Devices (legally marketed under K965001/K990144/K002489/KO11002) Device The Intuitive Surgical@Endoscopic Instrument Control System Description… | 2000 |
| * | K002489 | Intuitive Surgical DA Vinci Endoscopic Control SystemSummary page 1…ogic Laparoscope and Accessories (21 CFR 884.1720) Predicate da VinciTMSurgical System Devices (legally marketed under K965001/K990144/K002489/KO11002) Device The Intuitive Surgical@Endoscopic Instrument Control System Description (Model… | 2001 |
| * | K011002 | Intuitive Surgical DA Vinci Surgical System, Model Isi 1000 | 2001 |
What descends from it? (260)
See all 26015 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic… | 2004 | 258 |
| K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &… | 2004 | 251 |
| K042855 | Intuitive Surgical Harmonic Curved Shears Instrument | 2004 | 235 |
| 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 |
| K043288 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | 2005 | 229 |
| K040948 | Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170 | 2004 | 229 |
| K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | 2005 | 228 |
| K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | 2006 | 224 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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 15, 2013 | Class II | Z-0521-2014 | Software design (manufacturing process) | Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. |
| Nov 15, 2013 | Class II | Z-0520-2014 | Software design (manufacturing process) | Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. |
| 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… |
| Mar 9, 2005 | Not classified | Z-0723-05 | Other | Blades on the scissor may break and separate from the main unit as a result of corrosion damage. |
The 5 latest of 18 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 8 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K040237 (Intuitive Surgical, Inc., 2004) has gone furthest, with 258 descendants of its own.
- 3 other devices also cite its predicate K965001.
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 VinctTMSystem”) is intended to assist in the accurate control of Intuitive Surgical’ endoscopicinstruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forcepdpick-ups, needle holders, endoscopic retractors, stabilizers, electrocauteryand accessories during laparoscopic surgical procedures such as…
Read the full statement (108 words)
The Intuitive Surgical@Endoscopic Instrument Control System (hereinafter referred to as the “da VinctTMSystem”) is intended to assist in the accurate control of Intuitive Surgical’ endoscopicinstruments including: rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forcepdpick-ups, needle holders, endoscopic retractors, stabilizers, electrocauteryand accessories during laparoscopic surgical procedures such as cholecystectomy,Nissen fundoplication,radical prostatectomy, and general non-cardiac thoracoscopic surgical procedures such as internal mammary artery mobilization. It is intended to be used by trained physicians in an operating room environment.
Intuitive Surgical’ Endoscopic Instruments including scissors, scalpels, forcepslpick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocauteryand suturing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021036 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021036: Intuitive Surgical DA Vinci Surgical System, Model IS1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021036
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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