510(k) · Cleared
Recalled · Class II · 2022Flexible Cmos-Video-Cysto-Urethroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FBO Cystourethroscope
Cleared on Jan 2, 2014 as substantially equivalent to K062918 (KARL STORZ Endoscopy-America, Inc., 2007) and 1 other predicate after a 234-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 2, 2014
- Review
- 234 days
- Class
- Class II
- Product code
- FBO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945185 (1995). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK945185 Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB)KARL STORZ Endoscopy-America, Inc. · 1995 · Recalled
- This deviceK131364 Flexible Cmos-Video-Cysto-UrethroscopeKARL STORZ Endoscopy-America, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK182723 Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK191357 Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK202957 Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK212476 KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc. · 2021 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K182723Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019 · cites it directly3descendants
- K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019 · 2 generations on2descendants
- K202957Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc. · 2020 · cites it directly1descendant
- K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945185 | Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB) | KARL STORZ Endoscopy-America, Inc. | 1995 | 1 |
| 0 (this device) | K131364 | Flexible Cmos-Video-Cysto-Urethroscope | KARL STORZ Endoscopy-America, Inc. | 2014 | — |
| +1 | 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 |
| +2 | K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | Karl Storz Endoscopy America, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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.
Planning a device in FBO? 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 FBO device
- #1 K244001 KARL STORZ Cysto-Urethro-Fiberscope…score 9.3 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K062918 | Karl Storz Flexible Video-Urethro-Cystoscope SystemSummary page 1…formation about devices to which Substantial Equivalence is claimed: 510 (K) Trade/ Proprietary Name/Model Number Manufacturer/ Number K06291 8 Flexible Video-Urethro-Cystoscope Systemn Karl Storz GrnbH- & Co. KG K945 185 Flexible Fiber… | 2007 |
| * | K945185 | Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB)Summary page 1…y Name/Model Number Manufacturer/ Number K06291 8 Flexible Video-Urethro-Cystoscope Systemn Karl Storz GrnbH- & Co. KG K945 185 Flexible Fiber Optic Cystoscope Karl Storz GmbH & Co. KG Page 1lof 4… | 1995 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2022 | Class II | Z-1062-2022 | Under Investigation by firm | Failure to achieve the expected six-log reduction in microorganisms following the disinfection process. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K182723 (KARL STORZ Endoscopy-America, Inc., 2019) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FBO devicesFBO Cystourethroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FBO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBO
Too few FBO 510(k)s in any year since 2007 to give a median.
Recalls per year · FBO
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBO
26in 2025
MAUDE reports naming product code FBO, 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 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 20 |
| 2021 | 0 | — | 0 | 18 |
| 2022 | 0 | — | 5 | 33 |
| 2023 | 0 | — | 1 | 29 |
| 2024 | 1 | — | 0 | 30 |
| 2025 | 1 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Flexible CMOS Video-Cysto-Urethroscope is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of the lower urinary tract including the bladder and urethra.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131364: Flexible Cmos-Video-Cysto-Urethroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131364
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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