510(k) · Cleared
Recalled · Class II · 2022KARL STORZ Flexible HD Cysto-Urethroscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy America, Inc. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Sep 3, 2021 as substantially equivalent to K191357 (KARL STORZ Endoscopy-America, Inc., 2019) and 1 other predicate after a 28-day review. Its family tree reaches back 9 generations to 1993. 1 of the 26 devices in its family, counting itself, has a Class I recall. It has been recalled once.
- Decided
- Sep 3, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K931154 (1993). 25 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations between
- 3 generations backK182723 Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
- 2 generations backK191357 Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
- 1 generation backK202957 Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc. · 2020 · Recalled
- This deviceK212476 KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 7 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 6 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 5 generations backK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- 4 generations backK133538 Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera…Olympus Corporation of the Americas · 2014
- 3 generations backK182723 Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
- 2 generations backK191357 Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
- 1 generation backK202957 Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc. · 2020 · Recalled
- This deviceK212476 KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc. · 2021
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope6 generations back · 1991
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −8 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −7 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −6 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −5 | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| −4 | K133538 | Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro… | Olympus Corporation of the Americas | 2014 | — |
| −3 | K182723 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019 | — |
| −2 | K191357 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019 | — |
| −1 | K202957 | Flexible Video Cysto-Urethroscope (C-view) | KARL STORZ Endoscopy-America, Inc. | 2020 | 2 |
| 0 (this device) | K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | Karl Storz Endoscopy America, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 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.
1 device in this family has 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 FAJ device
- #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 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 |
|---|---|---|---|
| * | K191357 | Flexible HD Cysto-Urethroscope SystemSummary page 4…roduct Code: FAJ, FBO Regulation Name / Endoscope and Accessories (21 CFR 876.1500) Number: Predicate Device(s): Flexible HD Cysto-Urethroscope System (K191357) – Primary Flexible Video Cysto-Urethroscope (C-View) (K202957) – Secondary **The a… | 2019 |
| * | K202957 | Flexible Video Cysto-Urethroscope (C-view)Summary page 4…FR 876.1500) Number: Predicate Device(s): Flexible HD Cysto-Urethroscope System (K191357) – Primary Flexible Video Cysto-Urethroscope (C-View) (K202957) – Secondary **The above predicate devices have not been subject to any recall**… | 2020 |
| † | K201135 | Image1 S CCU, Image1 S 4U Camera Head | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2022 | Class II | Z-1063-2022 | 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 · 6 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 15 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K191357.
How does its category compare?
All FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, 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 | 2 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212476 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212476: KARL STORZ Flexible HD Cysto-Urethroscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212476
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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