510(k) · Cleared
ClearedFlexible Fiberscopes and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on May 21, 1998 as substantially equivalent to K962172 (Richard Wolf Medical Instruments Corp., 1996) after a 108-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.
- Decided
- May 21, 1998
- Review
- 108 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962172 (1996). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK962172 Flexible Mini-FiberscopesRichard Wolf Medical Instruments Corp. · 1996
- This deviceK980401 Flexible Fiberscopes and AccessoriesRichard Wolf Medical Instruments Corp. · 1998
- Descendant · cites it directly · 3 of its ownK992526 Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeRichard Wolf Medical Instruments Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK132039 Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N SlimJedmed Instrument Co. · 2014
- Descendant · 3 generations on · 0 of its ownK150248 ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company · 2015
- Descendant · 2 generations on · 0 of its ownK070580 Nasopharyngoscope, BronchoscopeXion GmbH · 2007
- Descendant · cites it directly · 0 of its ownK051176 Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and…Richard Wolf Medical Instruments Corp. · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K992526Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeRichard Wolf Medical Instruments Corp. · 1999 · cites it directly3descendants
- K132039Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N SlimJedmed Instrument Co. · 2014 · 2 generations on1descendant
- K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company · 2015 · 3 generations on0descendants
- K070580Nasopharyngoscope, BronchoscopeXion GmbH · 2007 · 2 generations on0descendants
- K051176Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066Richard Wolf Medical Instruments Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962172 | Flexible Mini-Fiberscopes | Richard Wolf Medical Instruments Corp. | 1996 | — |
| 0 (this device) | K980401 | Flexible Fiberscopes and Accessories | Richard Wolf Medical Instruments Corp. | 1998 | — |
| +1 | K992526 | Flexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope | Richard Wolf Medical Instruments Corp. | 1999 | — |
| +2 | K132039 | Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N Slim | Jedmed Instrument Co. | 2014 | — |
| +3 | K150248 | ORL Video NasoPharyngo-Larngoscope | Jedmed Instrument Company | 2015 | — |
| +2 | K070580 | Nasopharyngoscope, Bronchoscope | Xion GmbH | 2007 | — |
| +1 | K051176 | Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066 | Richard Wolf Medical Instruments Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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 FAJ? 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 FAJ device
- #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K962172 | Flexible Mini-FiberscopesSummary page 1…ification name: Flexxble endoscopes :Informat:on on devxces to whlch substantlal eqmvalence ls clalmed 510(k) Number Trade or proprietary or model name Manufacturer I K962172 1 Flexible Mini-Fiberscopes 1 Richard Wolf 2 2 Flexible CystoNephroscope ACN 2 Circon/ ACMI 3 3 Flexible Hysteroscope, AUR-FH 3 C… | 1996 |
| * | — | Flexible CystoNephroscope ACN Named without a submission number | |
| * | — | Flexible Hysteroscope, AUR-FH Named without a submission number | |
| * | — | Cysto-Urethro-Fiberscope 11272 AA Named without a submission number | |
| * | — | Flexible Hysteroscope, 11261 BB Named without a submission number | |
| * | — | Flexible Cystofiberscope CYF-3 Named without a submission number | |
| * | — | Hysterofiberscope, HYF-1T Named without a submission number |
What descends from it? (6)
3 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 FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, 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 | 2 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
For examination, diagnosis and/or therapy in connection with endoscopic accessories and auxiliary instruments used through the working channel of the instrument for use in urology, surgery, and GYN.
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/K980401 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980401: Flexible Fiberscopes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980401
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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