510(k) · Cleared
ClearedHOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz-Endoscopy-America, Inc. · OWN Confocal Optical Imaging
Cleared on Aug 17, 2020 as substantially equivalent to K180146 (Karl Storz Endoscopy America, Inc., 2018) after an 81-day review. Its family tree reaches back 17 generations to 1994. 8 later devices descend from it.
- Decided
- Aug 17, 2020
- Review
- 81 days
- Class
- Class II
- Product code
- OWN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K930667 (1994). 94 ancestors in all, the oldest K811390 (1981). 8 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 13 generations between
- 3 generations backK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- 2 generations backK171238 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- 1 generation backK180146 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018
- This deviceK201399 HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°…Karl Storz-Endoscopy-America, Inc. · 2020
- Descendant · cites it directly · 7 of its ownK202925 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK212695 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America · 2021
- Descendant · 3 generations on · 2 of its ownK233333 KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG · 2023
- Descendant · 3 generations on · 0 of its ownK262547 KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG · 2026
- Descendant · 4 generations on · 0 of its ownK254242 KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG · 2026
Show all 17 generations
- Root · 17 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 16 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 15 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 14 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 13 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 12 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 11 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 10 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 9 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 8 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 7 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 6 generations backK101077 DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc. · 2011 · Recalled
- 5 generations backK124031 DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc. · 2013
- 4 generations backK152583 KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2016
- 3 generations backK162882 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- 2 generations backK171238 KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. · 2017
- 1 generation backK180146 KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc. · 2018
- This deviceK201399 HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°…Karl Storz-Endoscopy-America, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K202925KARL STORZ ICG Imaging SystemKarl Storz Endoscopy_America, Inc. · 2020 · cites it directly7descendants
- K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America · 2021 · 2 generations on5descendants
- K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG · 2023 · 3 generations on2descendants
- K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG · 2026 · 3 generations on0descendants
- K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −16 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −15 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −14 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −13 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −12 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −11 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −10 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −9 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −8 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −7 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −6 | K101077 | DA Vinci Fluorescence Imaging Vision System, Model FF 100 | Intuitive Surgical, Inc. | 2011 | 2 |
| −5 | K124031 | DA Vinci Fluorescence Imaging Vision System | Intuitive Surgical, Inc. | 2013 | — |
| −4 | K152583 | KARL STORZ Endoscopic ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2016 | — |
| −3 | K162882 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| −2 | K171238 | KARL STORZ ICG Imaging System | KARL STORZ Endoscopy-America, Inc. | 2017 | — |
| −1 | K180146 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America, Inc. | 2018 | — |
| 0 (this device) | K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR… | Karl Storz-Endoscopy-America, Inc. | 2020 | — |
| +1 | K202925 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy_America, Inc. | 2020 | — |
| +2 | K212695 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy America | 2021 | — |
| +3 | K233333 | KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit | Karl Storz SE & CO. KG | 2023 | — |
| +3 | K262547 | KARL STORZ TIPCAM1 Rubina | KALR STORZ SE & Co. KG | 2026 | — |
| +4 | K254242 | KARL STORZ ICG Imaging System with RUBINA® Lens | Karl Storz SE & CO. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 10 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 OWN? 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 OWN device
- #1 K231854 1788 4K Camera System with Advanced Imaging…score 25.0 · 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? (1)
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 |
|---|---|---|---|
| * | K180146 | KARL STORZ ICG Imaging SystemSummary page 4…egulation: 21 CFR 876.1500 (Endoscope and Accessories) 21 CFR 882.1480 (Neurological Endoscopes) Predicate KARL STORZ ICG Imaging System (K180146) Device(s): Device The modified KARL STORZ ICG Imaging System includes the Description: following components:… | 2018 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202925 | KARL STORZ ICG Imaging System | 2020 | 7 |
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 26 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 19 of the 94 ancestors have a recall of any class.
- Of its descendants, K202925 (Karl Storz Endoscopy_America, Inc., 2020) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K180146.
How does its category compare?
All OWN devicesOWN Confocal Optical Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OWN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWN
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWN
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWN
197in 2025
MAUDE reports naming product code OWN, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 3 | 87 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 208 | 0 | 0 |
| 2015 | 5 | 163 | 0 | 1 |
| 2016 | 2 | — | 0 | 4 |
| 2017 | 5 | 87 | 0 | 12 |
| 2018 | 1 | — | 0 | 11 |
| 2019 | 7 | 81 | 0 | 59 |
| 2020 | 7 | 81 | 0 | 105 |
| 2021 | 4 | 104 | 0 | 312 |
| 2022 | 4 | 41 | 3 | 346 |
| 2023 | 6 | 69 | 0 | 164 |
| 2024 | 1 | — | 1 | 165 |
| 2025 | 3 | 196 | 0 | 197 |
| 2026 | 7 | 63 | 0 | — |
What is it indicated for?
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The KARL STORZ Endoscopic ICG 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 and common hepatic duct), using…
Read the full statement (235 words)
The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.
The KARL STORZ Endoscopic ICG 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 and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG 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.
Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.
The KARL STORZ VITOM II ICG System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201399 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201399: HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201399
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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