510(k) · Cleared
ClearedApn-2 Usa Series Flexible Choledochoscope
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 9, 2001 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 107 devices in its family, counting itself, has a Class I recall. 106 later devices descend from it.
- Decided
- Nov 9, 2001
- Review
- 66 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 0
106 later devices descend from it, 2 citing it directly. 1 of the 107 devices in this family, counting this one, has a Class I recall.
- This deviceK012951 Apn-2 Usa Series Flexible CholedochoscopeCircon Video · 2001
- Descendant · cites it directly · 103 of its ownK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- Descendant · 2 generations on · 101 of its ownK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 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 · 2 generations on · 99 of its ownK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- Descendant · 3 generations on · 53 of its ownK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233472 CVAC Aspiration System + CVAC Image Processor5 generations on · 2024
Most influential descendants
Showing 5 of 106 · See all- K030960Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003 · cites it directly103descendants
- K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004 · 2 generations on101descendants
- 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 · 2 generations on99descendants
- K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · 3 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012951 | Apn-2 Usa Series Flexible Choledochoscope | Circon Video | 2001 | — |
| +1 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| +2 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| +1 | K023358 | Usa Series Dur 8 Elite, Usa Series Dur 8, Models Dur 8E, Dur 8 | Acmi Corporation | 2003 | — |
| +2 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| +3 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 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? (106)
See all 1062 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 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K030960 (Acmi Corporation, 2003) has gone furthest, with 103 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 CIRCON ACMI USA Series™ APN-2 Flexible Choledochoscope may be used in the biliary tract for diagnostic and therapeutic treatment of ductal stones during laparoscopic cholecystectomy.
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/K012951 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012951: Apn-2 Usa Series Flexible Choledochoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012951
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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