510(k) · Cleared
Recalled · Class II · 2022Karl Storz Flexible Video-Urethro-Cystoscope System
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 17, 2007 after a 111-day review. The FDA summary names no predicate by number. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 17, 2007
- Review
- 111 days
- Class
- Class II
- Product code
- FBO
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK062918 Karl Storz Flexible Video-Urethro-Cystoscope SystemKARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK131364 Flexible Cmos-Video-Cysto-UrethroscopeKARL STORZ Endoscopy-America, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK182723 Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK191357 Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK202957 Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK212476 KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc. · 2021 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K131364Flexible Cmos-Video-Cysto-UrethroscopeKARL STORZ Endoscopy-America, Inc. · 2014 · cites it directly4descendants
- K182723Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019 · 2 generations on3descendants
- K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc. · 2019 · 3 generations on2descendants
- K202957Flexible Video Cysto-Urethroscope (C-view)KARL STORZ Endoscopy-America, Inc. · 2020 · 2 generations on1descendant
- K212476KARL STORZ Flexible HD Cysto-Urethroscope SystemKarl Storz Endoscopy America, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062918 | Karl Storz Flexible Video-Urethro-Cystoscope System | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +1 | K131364 | Flexible Cmos-Video-Cysto-Urethroscope | KARL STORZ Endoscopy-America, Inc. | 2014 | 1 |
| +2 | K182723 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019 | — |
| +3 | K191357 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | 2019 | — |
| +2 | K202957 | Flexible Video Cysto-Urethroscope (C-view) | KARL STORZ Endoscopy-America, Inc. | 2020 | 2 |
| +3 | K212476 | KARL STORZ Flexible HD Cysto-Urethroscope System | Karl Storz Endoscopy America, Inc. | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131364 | Flexible Cmos-Video-Cysto-Urethroscope | 2014 | 4 |
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-1064-2022 | 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?
- Of its descendants, K131364 (KARL STORZ Endoscopy-America, Inc., 2014) has gone furthest, with 4 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. 2007, 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 Karl Storz Video-Urethro-Cystoscope System is intended for use by physicians in the visual examination and treatment of a variety of urological endoscopic procedures. The Video-Urethro-Cystoscope is intended to provide optical visualization via a video monitor and therapeutic access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062918 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062918: Karl Storz Flexible Video-Urethro-Cystoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062918
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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