510(k) · Cleared
Recalled · Class II · 2022Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB)
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 May 3, 1995 after a 191-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- May 3, 1995
- Review
- 191 days
- Class
- Class II
- Product code
- FBO
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK945185 Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB)KARL STORZ Endoscopy-America, Inc. · 1995
- 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 · cites it directly · 0 of its ownK244001 KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ…Karl Storz SE & CO. KG · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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
- K244001KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope…Karl Storz SE & CO. KG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945185 | Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB) | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| +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 |
| +1 | K244001 | KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ… | Karl Storz SE & CO. KG | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
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-1061-2022 | 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.
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 | — |
https://510kreport.com/device/K945185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945185: Cystoscope (78FAJ)Endoscope,Fiberoptic (78GDB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945185
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026