510(k) · Cleared
Clearedda Vinci Firefly Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical · NAY System, Surgical, Computer Controlled Instrument
Cleared on May 22, 2026 as substantially equivalent to K251202 (Intuitive Surgical, Inc., 2025) and 1 other predicate after an 80-day review. Its family tree reaches back 26 generations to 1994. 6 of the 220 devices in its family, counting itself, have a Class I recall.
- Decided
- May 22, 2026
- Review
- 80 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 26 generations to K930667 (1994). 219 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet. 6 of the 220 devices in this family, counting this one, have a Class I recall.
- Root · 26 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 22 generations between
- 3 generations backK223080 da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System…Intuitive Surgical, Inc. · 2022
- 2 generations backK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024 · Recalled
- 1 generation backK251202 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2025
- This deviceK260695 da Vinci Firefly Imaging SystemIntuitive Surgical · 2026
Show all 26 generations
- Root · 26 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 25 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 24 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 23 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 22 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 21 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 20 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 19 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 18 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 17 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 16 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 15 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 14 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 13 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 12 generations backK152578 da Vinci Surgical System, Model IS4000Intuitive Surgical, Inc. · 2016
- 11 generations backK153276 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2016
- 10 generations backK170713 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2017
- 9 generations backK171632 da Vinci Xi Surgical SystemIntuitive Surgical, Inc. · 2017
- 8 generations backK173842 da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018
- 7 generations backK182140 da Vinci Xi Surgical System, da Vinci X Surgical SystemIntuitive Surgical, Inc. · 2018
- 6 generations backK183086 da Vinci X and Xi Surgical SystemIntuitive Surgical, Inc. · 2020
- 5 generations backK202834 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System…Intuitive Surgical, Inc. · 2020
- 4 generations backK211784 da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System…Intuitive Surgical, Inc. · 2021
- 3 generations backK223080 da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System…Intuitive Surgical, Inc. · 2022
- 2 generations backK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024 · Recalled
- 1 generation backK251202 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2025
- This deviceK260695 da Vinci Firefly Imaging SystemIntuitive Surgical · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −25 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −24 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −23 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −22 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −21 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −20 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −19 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −18 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −17 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −16 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −15 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −14 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −13 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −12 | K152578 | da Vinci Surgical System, Model IS4000 | Intuitive Surgical, Inc. | 2016 | — |
| −11 | K153276 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2016 | — |
| −10 | K170713 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2017 | — |
| −9 | K171632 | da Vinci Xi Surgical System | Intuitive Surgical, Inc. | 2017 | — |
| −8 | K173842 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018 | — |
| −7 | K182140 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical, Inc. | 2018 | — |
| −6 | K183086 | da Vinci X and Xi Surgical System | Intuitive Surgical, Inc. | 2020 | — |
| −5 | K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | 2020 | — |
| −4 | K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | 2021 | — |
| −3 | K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) | Intuitive Surgical, Inc. | 2022 | — |
| −2 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with… | Intuitive Surgical, Inc. | 2024 | 6 |
| −1 | K251202 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025 | — |
| 0 (this device) | K260695 | da Vinci Firefly Imaging System | Intuitive Surgical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 7 | 1 |
| 1992 | 4 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 0 |
| 1997 | 12 | 0 |
| 1998 | 7 | 0 |
| 1999 | 9 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 1 |
| 2003 | 9 | 1 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 10 | 1 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 1 |
| 2012 | 3 | 1 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 8 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 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.
6 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? (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 |
|---|---|---|---|
| * | K251202 | da Vinci Surgical System (IS5000)Summary page 5…nt 876.1500 NAY, GCJ, IZI 21 CFR 807.92(a)(3) | Legally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K251202 da Vinci Surgical System Model IS5000/Gen5 NAY K231854 1788 4K Camera System with Advanced Imaging Modality OWN Device Descripti… | 2025 |
| * | K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMSummary page 5…ally Marketed Predicate Devices Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K251202 da Vinci Surgical System Model IS5000/Gen5 NAY K231854 1788 4K Camera System with Advanced Imaging Modality OWN Device Description Summary 21 CFR 807.92(a)(4) The Firefly Imaging Sys… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 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.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations back · ◆ in the 2006 ancestors bar of FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 6 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 7 generations back · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall
- K014166Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002 · 8 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 61 of the 219 ancestors have a recall of any class; 6 have a Class I recall.
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. 2026, 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?
Fluorescence Imaging Vision System (Firefly Imaging System) Indications for Use: Upon intravenous administration and use of an ICG drug product consistent with its approved label, the da Vinci Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual…
Read the full statement (207 words)
Fluorescence Imaging Vision System (Firefly Imaging System) Indications for Use:
Upon intravenous administration and use of an ICG drug product consistent with its approved label, the da Vinci Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration and use of an ICG drug product consistent with its approved label, the da Vinci Firefly Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Upon administration and use of pafolacianine consistent with its approved label, the da Vinci Firefly Imaging System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.
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/K260695 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260695: da Vinci Firefly Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260695
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026