510(k) · Cleared
Recalled · Class I · 2024Urf-P2 Ureterorenofiberscope/Choledochofiberscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on Aug 7, 1991 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 of the 274 devices in its family, counting itself, have a Class I recall. 273 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Aug 7, 1991
- Review
- 85 days
- Class
- Class II
- Product code
- FBN
- Recalls
- 2 (1 Class I)
- Predicates
- 0
273 later devices descend from it, 4 citing it directly. 6 of the 274 devices in this family, counting this one, have a Class I recall.
- This deviceK912120 Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991
- Descendant · cites it directly · 268 of its ownK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- Descendant · 2 generations on · 158 of its ownK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- Descendant · 3 generations on · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- Descendant · 2 generations on · 103 of its ownK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- Descendant · 3 generations on · 101 of its ownK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
Showing 5 of 273 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 273 · See all- K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002 · cites it directly268descendants
- K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006 · 2 generations on158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · 3 generations on132descendants
- K030960Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003 · 2 generations on103descendants
- K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004 · 3 generations on101descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912120 | Urf-P2 Ureterorenofiberscope/Choledochofiberscope | Olympus Corp. | 1991 | — |
| +1 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| +2 | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| +3 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| +2 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| +3 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 1 |
| 2014 | 7 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 14 | 0 |
| 2019 | 20 | 1 |
| 2020 | 22 | 0 |
| 2021 | 16 | 1 |
| 2022 | 17 | 0 |
| 2023 | 25 | 0 |
| 2024 | 37 | 1 |
| 2025 | 43 | 1 |
| 2026 | 27 | 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.
6 devices in this family have 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (273)
See all 2734 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2024 | Class I | Z-0905-2025 | Labeling design | Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device. |
| Dec 12, 2016 | Class II | Z-1251-2017 | Under Investigation by firm | Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation and insertion tubes which were stuck inside of… |
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.
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190)…Olympus Medical Systems Corp. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
- K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021074 (Olympus America, Inc., 2002) has gone furthest, with 268 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/K912120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912120: Urf-P2 Ureterorenofiberscope/Choledochofiberscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912120
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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