510(k) · Cleared
Recalled · Class II · 2022Flexible Video-Uretero-Renoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Nov 26, 2013 as substantially equivalent to K060269 (Acmi Corporation, 2006) and 1 other predicate after a 197-day review. Its family tree reaches back 7 generations to 1993. 2 of the 77 devices in its family, counting itself, have a Class I recall. 53 later devices descend from it. It has been recalled once.
- Decided
- Nov 26, 2013
- Review
- 197 days
- Class
- Class II
- Product code
- FGB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931154 (1993). 23 ancestors in all, the oldest K843084 (1985). 53 later devices descend from it, 5 citing it directly. 2 of the 77 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 6 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 5 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 4 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 3 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 2 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 1 generation backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- This deviceK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013
- Descendant · cites it directly · 23 of its ownK172098 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
- Descendant · cites it directly · 11 of its ownK141250 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014 · Recalled
- Descendant · cites it directly · 9 of its ownK180367 Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2018
- Descendant · 2 generations on · 7 of its ownK142556 Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK201293 Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2020
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 53 · See all- K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017 · cites it directly23descendants
- K141250Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014 · cites it directly11descendants
- K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2018 · cites it directly9descendants
- K142556Flexible Video-Uretero-Choledochoscope SystemKARL STORZ Endoscopy-America, Inc. · 2014 · 2 generations on7descendants
- K201293Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. · 2020 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −6 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −5 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −4 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −3 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −2 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −1 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| 0 (this device) | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | — |
| +1 | K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017 | — |
| +1 | K141250 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2014 | 2 |
| +1 | K180367 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2018 | — |
| +2 | K142556 | Flexible Video-Uretero-Choledochoscope System | KARL STORZ Endoscopy-America, Inc. | 2014 | — |
| +2 | K201293 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 1 |
| 2025 | 14 | 0 |
| 2026 | 9 | 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.
2 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 FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 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 |
|---|---|---|---|
| * | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope SystemSummary page 1…noscope System is substantially equivalent to the ACMI Dur-Digital Ureteroscope and Choledochoscope System (K060269, including the Invisio Digital Controller) and the Karl Storz Imaging , New Camera… | 2006 |
| * | K003325 | Ksi's New Camera Architecture (Nca) Video Imaging SystemSummary page 1…nvisio Digital Controller) and the Karl Storz Imaging , New Camera Architecture (NCA) Video Imaging System (K003325) Indications For Use: The Karl Storz Flexible Video-Uretero-Renoscope System is indicat… | 2001 |
What descends from it? (53)
See all 535 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172098 | Medical Video Endoscope System | 2017 | 23 |
| K141250 | Flexible Video-Uretero-Renoscope System | 2014 | 11 |
| K180367 | Ureterorenoscope System | 2018 | 9 |
| K171076 | Medical Video Endoscope System | 2017 | 4 |
| K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA… | 2019 | 1 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2022 | Class II | Z-1068-2022 | Under Investigation by firm | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
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.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 2 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 23 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K172098 (Zhuhai Pusen Medical Technology Co., Ltd., 2017) has gone furthest, with 23 descendants of its own.
- 6 other devices also cite its predicate K060269.
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
The Karl Storz Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131369: Flexible Video-Uretero-Renoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131369
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