510(k) · Cleared
ClearedCholedochoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen HugeMed Medical Technical Development Co., Ltd. · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on Mar 6, 2024 as substantially equivalent to K210579 (OTU Medical, Inc., 2021) after a 287-day review. Its family tree reaches back 11 generations to 1993. 1 of the 28 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 6, 2024
- Review
- 287 days
- Class
- Class II
- Product code
- FBN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K931154 (1993). 27 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations between
- 3 generations backK171076 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
- 2 generations backK181977 WiScope Digital Endoscope SystemOTU Medical, Inc. · 2018
- 1 generation backK210579 WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…OTU Medical, Inc. · 2021
- This deviceK231497 Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 10 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 9 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 8 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 7 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 6 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 5 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 4 generations backK131369 Flexible Video-Uretero-Renoscope SystemKARL STORZ Endoscopy-America, Inc. · 2013 · Recalled
- 3 generations backK171076 Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. · 2017
- 2 generations backK181977 WiScope Digital Endoscope SystemOTU Medical, Inc. · 2018
- 1 generation backK210579 WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…OTU Medical, Inc. · 2021
- This deviceK231497 Choledochoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd. · 2024
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope6 generations back · 1991
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −10 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −9 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −8 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −7 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −6 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −5 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −4 | K131369 | Flexible Video-Uretero-Renoscope System | KARL STORZ Endoscopy-America, Inc. | 2013 | 1 |
| −3 | K171076 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017 | — |
| −2 | K181977 | WiScope Digital Endoscope System | OTU Medical, Inc. | 2018 | — |
| −1 | K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible… | OTU Medical, Inc. | 2021 | — |
| 0 (this device) | K231497 | Choledochoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2003 | 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.
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? (1)
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 |
|---|---|---|---|
| * | K210579 | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible…Summary page 5…oledochoscope And Classification Accessories, Flexible/Rigid / FBN, FET Submission type Traditional 510(K) 4. Predicate Device 510(k) number: K210579 Product name: WiScope® OM Endoscope System Submitter: OTU Medical Inc. 5. Device Description The Choledochoscope System consists… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 6 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 8 of the 27 ancestors have a recall of any class; 1 has a Class I recall.
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. 2024, 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?
Choledochoscope System is intended to be used by physicians through percutaneous insertion to access, visualize, and
perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct.
The image processor provides illumination for the choledochoscope, and is also used to receive the signal from the
endoscope, convert it into an image and display it on the examination monitor.
The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets
at a surgical site
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231497 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231497: Choledochoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231497
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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