510(k) · Cleared
Clearedda Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging 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 Apr 26, 2021 as substantially equivalent to K124031 (Intuitive Surgical, Inc., 2013) and 1 other predicate after a 28-day review. Its family tree reaches back 15 generations to 1994. 6 later devices descend from it.
- Decided
- Apr 26, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- NAY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K930667 (1994). 81 ancestors in all, the oldest K811390 (1981). 6 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 11 generations between
- 3 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 2 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 1 generation backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- This deviceK210918 da Vinci Fluorescence Imaging Vision System, da Vinci Firefly…Intuitive Surgical, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK213710 da Vinci Fluorescence Imaging Vision System, da Vinci Firefly…Intuitive Surgical, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK212101 da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK250786 SP Endoscope, 0° (430600)Intuitive Surgical, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK252350 da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233892 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd. · 2024
Show all 15 generations
- Root · 15 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 14 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 13 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 12 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 11 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 10 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 9 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 8 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 7 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 6 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 5 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 4 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 3 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 2 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 1 generation backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- This deviceK210918 da Vinci Fluorescence Imaging Vision System, da Vinci Firefly…Intuitive Surgical, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213710da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2022 · cites it directly2descendants
- K212101da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc. · 2021 · cites it directly2descendants
- K250786SP Endoscope, 0° (430600)Intuitive Surgical, Inc. · 2025 · 2 generations on1descendant
- K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc. · 2025 · 3 generations on0descendants
- K2338923D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)Zhuhai Dipu Medical Technology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −14 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −13 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −12 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −11 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −10 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −9 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −8 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −7 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −6 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −5 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −4 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −3 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −2 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −1 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
| 0 (this device) | K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2021 | — |
| +1 | K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2022 | — |
| +1 | K212101 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | 2021 | — |
| +2 | K250786 | SP Endoscope, 0° (430600) | Intuitive Surgical, Inc. | 2025 | — |
| +3 | K252350 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | 2025 | — |
| +2 | K233892 | 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) | Zhuhai Dipu Medical Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 9 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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.
Planning a device in NAY? 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 |
|---|---|---|---|
| * | K124031 | DA Vinci Fluorescence Imaging Vision SystemSummary page 4…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code I K124031 da Vinci Fluorescence Imaging Vision System NAY I K141077… | 2013 |
| * | K141077 | DA Vinci Firefly Imaging SystemSummary page 4…Product Code I K124031 da Vinci Fluorescence Imaging Vision System NAY I K141077 da Vinci Firefly Imaging System NAY… | 2014 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 24 of the 81 ancestors have a recall of any class.
- Of its descendants, K213710 (Intuitive Surgical, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K124031.
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. 2021, 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?
Da Vinci Fluorescence Imaging Vision System: The da Vinci Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision 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 extra-hepatic bile…
Read the full statement (234 words)
Da Vinci Fluorescence Imaging Vision System:
The da Vinci Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision 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 extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging.
Fluorescence imaging of biliary ducts with the da Vinci Fluorescence Imaging Vision 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.
Da Vinci Firefly Imaging System:
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 extra-hepatic 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210918: da Vinci Fluorescence Imaging Vision System, 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/K210918
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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