510(k) · Cleared
Recalled · Class II · 2015DA 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 Aug 12, 2014 as substantially equivalent to K131861 (Intuitive Surgical, Inc., 2014) and 2 other predicates after a 109-day review. Its family tree reaches back 14 generations to 1994. 87 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 12, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- NAY
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 14 generations to K930667 (1994). 80 ancestors in all, the oldest K811390 (1981). 87 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 10 generations between
- 3 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 2 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 1 generation backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- This deviceK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014
- Descendant · cites it directly · 70 of its ownK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 68 of its ownK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- Descendant · 2 generations on · 44 of its ownK182606 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018
- Descendant · 2 generations on · 33 of its ownK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
- Descendant · 3 generations on · 26 of its ownK202592 Adavanced Imaging Modality System (1688 4K Camera System With…Stryker · 2020
Show all 14 generations
- Root · 14 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 13 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 12 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 11 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 10 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 9 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 8 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 7 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 6 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 5 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 4 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 3 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 2 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 1 generation backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- This deviceK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014
Showing 5 of 87 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 87 · See all- K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · cites it directly70descendants
- K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · 2 generations on68descendants
- K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2018 · 2 generations on44descendants
- K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker · 2018 · 2 generations on33descendants
- K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker · 2020 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −13 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −12 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −11 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −10 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −9 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −8 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −7 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −6 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −5 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −4 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −3 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −2 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −1 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| 0 (this device) | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | — |
| +1 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
| +2 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | — |
| +2 | K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2018 | — |
| +2 | K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K… | Stryker | 2018 | 1 |
| +3 | K202592 | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging… | Stryker | 2020 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 15 | 0 |
| 2026 | 16 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131861 | DA Vinci Surgical System, Endowrist Instruments and AccessoriesSummary page 4…System, Surgical, Computer Controlled Instrument) Classification Advisory Committee: General and Plastic Surgery Predicate Device: da Vincig Xi Surgical System device, K131861 da Vincig Fluorescence Imaging Vision System, K101077 da Vincig Fluorescence Imaging Vision System, K124031 Device Description… | 2014 |
| * | K101077 | DA Vinci Fluorescence Imaging Vision System, Model FF 100Summary page 4…ification Advisory Committee: General and Plastic Surgery Predicate Device: da Vincig Xi Surgical System device, K131861 da Vincig Fluorescence Imaging Vision System, K101077 da Vincig Fluorescence Imaging Vision System, K124031 Device Description The Intuitive Surgical da Vincig Firefly™ Imaging Syst… | 2011 |
| * | K124031 | DA Vinci Fluorescence Imaging Vision SystemSummary page 4…gery Predicate Device: da Vincig Xi Surgical System device, K131861 da Vincig Fluorescence Imaging Vision System, K101077 da Vincig Fluorescence Imaging Vision System, K124031 Device Description The Intuitive Surgical da Vincig Firefly™ Imaging System uses the existing endoscopic imaging system as subm… | 2013 |
What descends from it? (87)
See all 874 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150956 | PINPOINT Endoscopic Fluorescence Imaging System | 2016 | 70 |
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke… | 2024 | 11 |
| K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | 2021 | 6 |
| K170641 | da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2015 | Class II | Z-2782-2015 | Package design/selection | B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility… |
| Nov 21, 2014 | Class II | Z-0835-2015 | Labeling design | The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the result would be a loss of fluorescence. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 23 of the 80 ancestors have a recall of any class.
- Of its descendants, K150956 (Novadaq Technologies, Inc., 2016) has gone furthest, with 70 descendants of its own.
- 31 other devices also cite its predicate K131861.
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. 2014, 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?
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)…
Read the full statement (110 words)
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141077: DA Vinci Firefly Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141077
Report an extraction error
Are you the manufacturer?
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