510(k) · Cleared
Recalled · Class III · 2023CHF-B20 Choledochoscope
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 Mar 27, 1991 after a 154-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it. It has been recalled once.
- Decided
- Mar 27, 1991
- Review
- 154 days
- Class
- Class II
- Product code
- FBN
- Recalls
- 1
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK904799 CHF-B20 CholedochoscopeOlympus Corp. · 1991
- Descendant · cites it directly · 13 of its ownK051886 Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation · 2005
- Descendant · 2 generations on · 10 of its ownK090170 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009
- Descendant · 3 generations on · 9 of its ownK142922 SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · Recalled
- Descendant · 4 generations on · 7 of its ownK181439 SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018
- Descendant · 5 generations on · 5 of its ownK183636 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and…Boston Scientific Corporation · 2019
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K051886Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation · 2005 · cites it directly13descendants
- K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009 · 2 generations on10descendants
- K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · 3 generations on9descendants
- K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018 · 4 generations on7descendants
- K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation · 2019 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904799 | CHF-B20 Choledochoscope | Olympus Corp. | 1991 | — |
| +1 | K051886 | Olympus Choledochoscope, Model XCHF-BP160F | Olympus Medical Systems Corporation | 2005 | — |
| +2 | K090170 | Spyscope Access and Delivery Catheter | Boston Scientific Corp | 2009 | — |
| +3 | K142922 | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | 2015 | 1 |
| +4 | K181439 | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | 2018 | — |
| +5 | K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery… | Boston Scientific Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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.
Planning a device in FBN? 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? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class III | Z-0330-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051886 (Olympus Medical Systems Corporation, 2005) has gone furthest, with 13 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/K904799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904799: CHF-B20 Choledochoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904799
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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