510(k) · Cleared
ClearedFlexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066
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 Oct 5, 2005 as substantially equivalent to K980401 (Richard Wolf Medical Instruments Corp., 1998) and 3 other predicates after a 152-day review. Its family tree reaches back 4 generations to 1993. 1 of the 21 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 5, 2005
- Review
- 152 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K931154 (1993). 20 ancestors in all, the oldest K843084 (1985). No later device cites it as a predicate yet. 1 of the 21 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 backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 1 generation backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- This deviceK051176 Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and…Richard Wolf Medical Instruments Corp. · 2005
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope2 generations back · 1991
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 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −1 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| 0 (this device) | K051176 | Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066 | Richard Wolf Medical Instruments Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 1 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 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 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? (5)
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 |
|---|---|---|---|
| * | K980401 | Flexible Fiberscopes and Accessories | 1998 |
| * | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VASummary page 1…eta or model name Manufacturer iK98040-1 I Flexible Fiberscopes and Accessories I Richard Wolf 2K 021074 2 Cysto-Videoscope VISERA CYF-V, 2 Olympus CYF-VA 3K30960… | 2002 |
| Kept off the family tree | K030960 | FDA’s K030960 is Ecn Electronic Video Cystonephroscope Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
| * | K023659 | 1-CCD Endocam 5520 SystemSummary page 1…F-V, 2 Olympus CYF-VA 3K30960 3 Digital Flexible Cysto-Videoscope DON 3 ACMI 4 K023659 4 1 CCD Endocam 5520 System 4 Richard Wolf 5 K983279 5 1 CCD Multi Endoca… | 2003 |
| * | K983279 | Endocam Camera Systems 5502 with Electronic CCD EndoscopeSummary page 1…Digital Flexible Cysto-Videoscope DON 3 ACMI 4 K023659 4 1 CCD Endocam 5520 System 4 Richard Wolf 5 K983279 5 1 CCD Multi Endocam 5502 with 5 Richard Wolf Electronic CCD Endos… | 1998 |
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 · 2 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 6 of the 20 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K980401.
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?
The Flexible Video Cystoscope is used for visualizing body cavities and organs via natural passages. For examination, diagnosis and/or therapy in conjunction with endoscopic accessories/ auxiliary instruments through the scope's working channel. The scope is used in the medical disciplines of
* Urology (urogenital tract, cystoscopy, nephroscopy)
* Surgery (choledochoscopy)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051176: Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051176
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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