510(k) · Cleared
ClearedFlexible Mini-Fiberscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on Dec 2, 1996 after a 180-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Dec 2, 1996
- Review
- 180 days
- Class
- Class II
- Product code
- FBN
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK962172 Flexible Mini-FiberscopesRichard Wolf Medical Instruments Corp. · 1996
- Descendant · cites it directly · 6 of its ownK980401 Flexible Fiberscopes and AccessoriesRichard Wolf Medical Instruments Corp. · 1998
- Descendant · 2 generations on · 3 of its ownK992526 Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeRichard Wolf Medical Instruments Corp. · 1999
- Descendant · 3 generations on · 1 of its ownK132039 Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N SlimJedmed Instrument Co. · 2014
- Descendant · 4 generations on · 0 of its ownK150248 ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company · 2015
- Descendant · 3 generations on · 0 of its ownK070580 Nasopharyngoscope, BronchoscopeXion GmbH · 2007
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K980401Flexible Fiberscopes and AccessoriesRichard Wolf Medical Instruments Corp. · 1998 · cites it directly6descendants
- K992526Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeRichard Wolf Medical Instruments Corp. · 1999 · 2 generations on3descendants
- K132039Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N SlimJedmed Instrument Co. · 2014 · 3 generations on1descendant
- K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company · 2015 · 4 generations on0descendants
- K070580Nasopharyngoscope, BronchoscopeXion GmbH · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962172 | Flexible Mini-Fiberscopes | Richard Wolf Medical Instruments Corp. | 1996 | — |
| +1 | K980401 | Flexible Fiberscopes and Accessories | Richard Wolf Medical Instruments Corp. | 1998 | — |
| +2 | K992526 | Flexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope | Richard Wolf Medical Instruments Corp. | 1999 | — |
| +3 | K132039 | Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N Slim | Jedmed Instrument Co. | 2014 | — |
| +4 | K150248 | ORL Video NasoPharyngo-Larngoscope | Jedmed Instrument Company | 2015 | — |
| +3 | K070580 | Nasopharyngoscope, Bronchoscope | Xion GmbH | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (6)
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 |
|---|---|---|---|
| * | — | Circon ACMI Model AUR-8 Named without a submission number | |
| * | — | Circon ACMI Model AUR-9 Named without a submission number | |
| * | — | Circon ACMI Model AUR-PN Named without a submission number | |
| * | — | Karl Storz Model 11274AA Named without a submission number | |
| * | — | Olympus Model PF-28 Named without a submission number | |
| * | — | Olympus Model URF-P2 Named without a submission number |
What descends from it? (8)
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?
- Of its descendants, K980401 (Richard Wolf Medical Instruments Corp., 1998) has gone furthest, with 6 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 | — |
What is it indicated for?
The flexible mini-fiberscopes are intended to be used in various Gastroenterology/Urology Procedures. These uses are: 1) Cystoscope - Used to examine the urinary tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures. 2) Choledochoscope - Used to examine the bile ducts, and using, additional accessories, to perform various diagnostic and therapeutic procedures. 3) Ureteroscope - Used to examine the ureter, and…
Read the full statement (181 words)
The flexible mini-fiberscopes are intended to be used in various Gastroenterology/Urology Procedures. These uses are:
1) Cystoscope - Used to examine the urinary tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
2) Choledochoscope - Used to examine the bile ducts, and using, additional accessories, to perform various diagnostic and therapeutic procedures.
3) Ureteroscope - Used to examine the ureter, and using additional accessories, to perform various diagnostic and therapeutic procedure.
4) Nephroscope - Used to examine the kidney, and with additional accessories, to perform various diagnostic and therapeutic accessories.
5) Uretero-renoscope - Used to examine the ureter and kidney, and additional accessories, to perform various diagnostic and therapeutic procedures.
Accessory Indications for use.
6) Flexible Biopsy Forceps - Used to obtain small biopsies from tissue.
7) Flexible Grasping Forceps - For grasping calculi, both renal and biliary.
8) Button Electrode - Used for unipolar coagqulation.
9) Dormia Stone Extractor - Used for grasping and removal of calculi, both renal and biliary.
10) Three Pronged Grasper - Used for grasping and removal of calculi, both renal and biliary.
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/K962172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962172: Flexible Mini-Fiberscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962172
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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