510(k) · Cleared
Recalled · Class II · 2016FCN-15X, Fiber Choledochonephroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Precision Instrument Corp. · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on May 30, 1995 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 105 devices in its family, counting itself, has a Class I recall. 104 later devices descend from it. It has been recalled once.
- Decided
- May 30, 1995
- Review
- 75 days
- Class
- Class II
- Product code
- FBN
- Recalls
- 1
- Predicates
- 0
104 later devices descend from it, 1 citing it directly. 1 of the 105 devices in this family, counting this one, has a Class I recall.
- This deviceK951191 FCN-15X, Fiber CholedochonephroscopePentax Precision Instrument Corp. · 1995
- 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 · 3 generations on · 99 of its ownK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- Descendant · 4 generations on · 53 of its ownK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 24 of its ownK153049 LithoVue SystemBoston Scientific Corporation · 2015
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233472 CVAC Aspiration System + CVAC Image Processor6 generations on · 2024
Most influential descendants
Showing 5 of 104 · 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
- K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006 · 3 generations on99descendants
- K131369Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · 4 generations on53descendants
- K153049LithoVue SystemBoston Scientific Corporation · 2015 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951191 | FCN-15X, Fiber Choledochonephroscope | Pentax Precision Instrument Corp. | 1995 | — |
| +1 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| +2 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| +3 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| +4 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| +4 | K153049 | LithoVue System | Boston Scientific Corporation | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 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), 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 FBN device
- #1 K254153 Single-use Video Scope; PB Digital Controllerscore 14.4 · 12 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (104)
See all 1041 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030960 | Ecn Electronic Video Cystonephroscope | 2003 | 103 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2016 | Class II | Z-2066-2016 | Device Design | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. |
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 · 6 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 FBN devicesFBN Choledochoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FBN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBN
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBN
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FBN
118in 2025
MAUDE reports naming product code FBN, 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 | 1 |
| 2008 | 3 | 64 | 0 | 5 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 168 |
| 2017 | 0 | — | 0 | 224 |
| 2018 | 1 | — | 0 | 639 |
| 2019 | 1 | — | 0 | 105 |
| 2020 | 1 | — | 1 | 173 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 0 | — | 0 | 283 |
| 2023 | 4 | 215 | 1 | 105 |
| 2024 | 2 | — | 1 (1) | 107 |
| 2025 | 3 | 150 | 0 | 118 |
| 2026 | 3 | 175 | 1 | — |
https://510kreport.com/device/K951191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951191: FCN-15X, Fiber Choledochonephroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951191
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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