510(k) · Cleared
ClearedDur-8, Models Dur-8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circon Video · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Nov 7, 2001 after a 68-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 103 devices in its family, counting itself, has a Class I recall. 102 later devices descend from it.
- Decided
- Nov 7, 2001
- Review
- 68 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 0
102 later devices descend from it, 2 citing it directly. 1 of the 103 devices in this family, counting this one, has a Class I recall.
- This deviceK012925 Dur-8, Models Dur-8Circon Video · 2001
- Descendant · cites it directly · 101 of its ownK023358 Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8Acmi Corporation · 2003
- Descendant · cites it directly · 99 of its ownK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- Descendant · 2 generations on · 53 of its ownK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 24 of its ownK153049 LithoVue SystemBoston Scientific Corporation · 2015
- Descendant · 3 generations on · 23 of its ownK172098 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233472 CVAC Aspiration System + CVAC Image Processor4 generations on · 2024
Most influential descendants
Showing 5 of 102 · See all- K023358Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8Acmi Corporation · 2003 · cites it directly101descendants
- K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006 · cites it directly99descendants
- K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · 2 generations on53descendants
- K153049LithoVue SystemBoston Scientific Corporation · 2015 · 2 generations on24descendants
- K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012925 | Dur-8, Models Dur-8 | Circon Video | 2001 | — |
| +1 | K023358 | Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8 | Acmi Corporation | 2003 | — |
| +1 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| +2 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| +2 | K153049 | LithoVue System | Boston Scientific Corporation | 2015 | — |
| +3 | K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 7 | 0 |
| 2020 | 4 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 10 | 0 |
| 2024 | 18 | 1 |
| 2025 | 18 | 0 |
| 2026 | 13 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (102)
See all 1022 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K023358 (Acmi Corporation, 2003) has gone furthest, with 101 descendants of its own.
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | 0 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
The intended use for this device is for therapeutic and diagnostic procedures in the entire intrarenal collecting system. These devices are marketed as reusable devices.
The methods for cleaning, disinfection, and sterilization are presented in “Sterility Information," Section 5 of this document.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012925 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012925: Dur-8, Models Dur-8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012925
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026