510(k) · Cleared
Recalled · Class II · 2022Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model 11278C1/Acui and Circon Aur-735 Pediatric Cystouretherosco
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 Oct 10, 2008 after an 84-day review. The FDA summary names no predicate by number. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 10, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- FBO
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK082046 Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model…KARL STORZ Endoscopy-America, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK241945 KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped.…Karl Storz SE & CO. KG · 2024
- Descendant · 2 generations on · 0 of its ownK243409 KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)Karl Storz SE & CO. KG · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082046 | Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model 11278C1/Acui and… | KARL STORZ Endoscopy-America, Inc. | 2008 | — |
| +1 | K241945 | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped.… | Karl Storz SE & CO. KG | 2024 | — |
| +2 | K243409 | KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) | Karl Storz SE & CO. KG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241945 | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped.… | 2024 | 1 |
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-1066-2022 | 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, K241945 (Karl Storz SE & CO. KG, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FBO devicesFBO Cystourethroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Pediatric Flexible Cysto-Urethro-Fiberscope and accessories are intended used for by a physican in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082046 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082046: Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope, Model 11278C1/Acui and Circon Aur-735 Pediatric Cystouretherosco.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082046
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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