510(k) · Cleared
ClearedOlympus Choledochoscope, Model XCHF-BP160F
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 14, 2005 as substantially equivalent to K904799 (Olympus Corp., 1991) and 1 other predicate after a 125-day review. Its family tree reaches back 4 generations to 1993. 1 of the 20 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.
- Decided
- Nov 14, 2005
- Review
- 125 days
- Class
- Class II
- Product code
- FBN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K931154 (1993). 6 ancestors in all, the oldest K904799 (1991). 13 later devices descend from it, 2 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 3 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 2 generations backK023984 Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series…The Olympus Optical Co. · 2003 · Recalled (Class I)
- 1 generation backK033225 Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its…Olympus Optical Co., Ltd. · 2003 · Recalled
- This deviceK051886 Olympus Choledochoscope, Model XCHF-BP160FOlympus Medical Systems Corporation · 2005
- Descendant · cites it directly · 10 of its ownK090170 Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009
- Descendant · 2 generations on · 9 of its ownK142922 SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · Recalled
- Descendant · 3 generations on · 7 of its ownK181439 SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018
- Descendant · 4 generations on · 5 of its ownK183636 SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and…Boston Scientific Corporation · 2019
- Descendant · 5 generations on · 3 of its ownK200483 SpyGlass Discover Digital Catheter, SpyGlass Discover Digital…Boston Scientific Corporation · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…2 generations back · 2003
Most influential descendants
Showing 5 of 13 · See all- K090170Spyscope Access and Delivery CatheterBoston Scientific Corp · 2009 · cites it directly10descendants
- K142922SpyGlass DS Direct Visualization SystemBoston Scientific Corporation · 2015 · 2 generations on9descendants
- K181439SpyGlass DS and DS II Direct Visualization SystemBoston Scientific Corporation · 2018 · 3 generations on7descendants
- K183636SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…Boston Scientific Corporation · 2019 · 4 generations on5descendants
- K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation · 2020 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −3 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −2 | K023984 | Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160… | The Olympus Optical Co. | 2003 | Class I |
| −1 | K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and… | Olympus Optical Co., Ltd. | 2003 | 5 |
| 0 (this device) | K051886 | Olympus Choledochoscope, Model XCHF-BP160F | Olympus Medical Systems Corporation | 2005 | — |
| +1 | K090170 | Spyscope Access and Delivery Catheter | Boston Scientific Corp | 2009 | — |
| +2 | K142922 | SpyGlass DS Direct Visualization System | Boston Scientific Corporation | 2015 | 1 |
| +3 | K181439 | SpyGlass DS and DS II Direct Visualization System | Boston Scientific Corporation | 2018 | — |
| +4 | K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery… | Boston Scientific Corporation | 2019 | — |
| +5 | K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | Boston Scientific Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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), 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.
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K904799 | CHF-B20 CholedochoscopeSummary page 1…arethepredicate medicaldevices; Model 510(k)# Manufacturer Class P-code OES Transduodenal Choledocho- #K904799 Olympus Optical Co., ]I KOG scope, CHF type B20 Ltd EVIS EXERA Bronchofibe… | 1991 |
| * | K033225 | Evis Exera Bronchofibervideoscope Olympus BF Type XP160F, Its Accessories and Ancillary…Summary page 1…ledocho- #K904799 Olympus Optical Co., ]I KOG scope, CHF type B20 Ltd EVIS EXERA Bronchofiber- #k033225 Olympus Optical Co., ]] EOO videoscope BF type XP160F Ltd D. General Description… | 2003 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 2 generations back · ◆ on the line of descent in FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K090170 (Boston Scientific Corp, 2009) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K904799.
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 | — |
What is it indicated for?
This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories (such as a biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the biliary tract and pancreatic duct in conjunction with DUODENOSCOPE with an instrument channel with a minimum diameter of *, 4.2mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051886 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051886: Olympus Choledochoscope, Model XCHF-BP160F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051886
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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