510(k) · Cleared
ClearedOlympus CHF Type V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on Nov 6, 2008 as substantially equivalent to K843084 (Olympus Corp., 1985) after a 167-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Nov 6, 2008
- Review
- 167 days
- Class
- Class II
- Product code
- FBN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K843084 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK843084 Olympus CHP-P10 Nephroscope/CystoscopeOlympus Corp. · 1985 · Recalled
- This deviceK081456 Olympus CHF Type VOlympus Medical Systems Corporation · 2008
- Descendant · cites it directly · 0 of its ownK231105 Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)Shanghai AnQing Medical Instrument Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK093507 Olympus CHF Type Y0003Olympus Medical Systems Corporation · 2010 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843084 | Olympus CHP-P10 Nephroscope/Cystoscope | Olympus Corp. | 1985 | 1 |
| 0 (this device) | K081456 | Olympus CHF Type V | Olympus Medical Systems Corporation | 2008 | — |
| +1 | K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2023 | — |
| +1 | K093507 | Olympus CHF Type Y0003 | Olympus Medical Systems Corporation | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K834 | OES Nephroscope / Cystoscope Fiberscope CHF-P10 Number could not be read Summary page 2…tial equivalence. Table 15-1: Prima Corn onent & Predicate Device CHOLEDOCHO VIDEOSCOPE OES Nephroscope / Cystoscope K834 CHF-V Fiberscope CHF-P10 4. Device Description The CHF-V choledochoscope Is a flexible… | |
| * | K843084 | Olympus CHP-P10 Nephroscope/CystoscopeSummary page 3…Table 15-2. Comparison of Specifications Subject Device: CHOLEDOCHO VIDEOSCOPE CHF-V Predicate Device: OES Nephroscope ICystoscope Fiberecope CHF-PI1 K843084 ° Field of View 12… | 1985 |
What descends from it? (2)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081456: Olympus CHF Type V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081456
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026