510(k) · Cleared
ClearedCholedochoscope/Endoscope Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujinon, Inc. · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on Jul 8, 1994 after a 331-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Jul 8, 1994
- Review
- 331 days
- Class
- Class II
- Product code
- FBN
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK933906 Choledochoscope/Endoscope ModificationFujinon, Inc. · 1994
- Descendant · cites it directly · 0 of its ownK964131 EndoscopeAkos Biomedical, Inc. · 1997
Most influential descendants
Showing 1 of 1 · See all- K964131EndoscopeAkos Biomedical, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933906 | Choledochoscope/Endoscope Modification | Fujinon, Inc. | 1994 | — |
| +1 | K964131 | Endoscope | Akos Biomedical, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K964131 | Endoscope | 1997 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K964131 (Akos Biomedical, Inc., 1997) has gone furthest, with 0 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/K933906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K933906: Choledochoscope/Endoscope Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K933906
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026