510(k) · Cleared
ClearedVisera Cystovideoscope Olympus Cyf Type V/VA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on May 2, 2002 as substantially equivalent to K993041 (The Olympus Optical Co., 2000) and 3 other predicates after a 30-day review. Its family tree reaches back 3 generations to 1993. 6 of the 279 devices in its family, counting itself, have a Class I recall. 268 later devices descend from it.
- Decided
- May 2, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K931154 (1993). 10 ancestors in all, the oldest K843084 (1985). 268 later devices descend from it, 5 citing it directly. 6 of the 279 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 2 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 1 generation backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- This deviceK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- Descendant · cites it directly · 158 of its ownK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- Descendant · 2 generations on · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- Descendant · cites it directly · 103 of its ownK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- Descendant · 2 generations on · 101 of its ownK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- Descendant · 3 generations on · 99 of its ownK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
Showing 5 of 268 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 268 · See all- K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006 · cites it directly158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · 2 generations on132descendants
- K030960Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003 · cites it directly103descendants
- K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004 · 2 generations on101descendants
- K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006 · 3 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −2 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −1 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| 0 (this device) | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| +1 | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| +2 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| +1 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| +2 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| +3 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
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 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 6 | 0 |
| 2013 | 7 | 1 |
| 2014 | 7 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 13 | 0 |
| 2019 | 18 | 1 |
| 2020 | 22 | 0 |
| 2021 | 16 | 1 |
| 2022 | 17 | 0 |
| 2023 | 25 | 0 |
| 2024 | 37 | 1 |
| 2025 | 43 | 1 |
| 2026 | 27 | 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.
6 devices in this family have 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? (4)
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 |
|---|---|---|---|
| * | K993041 | Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary EquipmentSummary page 4…t Classification: 21 CFR 876.1500 Endoscope and accessories, 21 CFR 876.4300 Endoscopic electrosurgical unit and accessories, Class I Predicate Device: XCYF-1T3 (K# 993041) URF-P2 (K# 912120) BF-200 (K# 931154) LE-TP/DP (K# 981543) Page 22 D. Description of the Device(s) The subjec… | 2000 |
| * | K912120 | Urf-P2 Ureterorenofiberscope/CholedochofiberscopeSummary page 4…21 CFR 876.1500 Endoscope and accessories, 21 CFR 876.4300 Endoscopic electrosurgical unit and accessories, Class I Predicate Device: XCYF-1T3 (K# 993041) URF-P2 (K# 912120) BF-200 (K# 931154) LE-TP/DP (K# 981543) Page 22 D. Description of the Device(s) The subject device is used for… | 1991 |
| * | K931154 | Evis 200 SystemSummary page 4…oscope and accessories, 21 CFR 876.4300 Endoscopic electrosurgical unit and accessories, Class I Predicate Device: XCYF-1T3 (K# 993041) URF-P2 (K# 912120) BF-200 (K# 931154) LE-TP/DP (K# 981543) Page 22 D. Description of the Device(s) The subject device is used for cndoscopic diagnos… | 1993 |
| * | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and Ancillary…Summary page 4…s, 21 CFR 876.4300 Endoscopic electrosurgical unit and accessories, Class I Predicate Device: XCYF-1T3 (K# 993041) URF-P2 (K# 912120) BF-200 (K# 931154) LE-TP/DP (K# 981543) Page 22 D. Description of the Device(s) The subject device is used for cndoscopic diagnosis and treatment with… | 1998 |
What descends from it? (268)
See all 2685 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 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 · Direct predicate · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
- K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope (Olympus BF-P190)…Olympus Medical Systems Corp. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 14 Class I recalls
- K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 6 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K062049 (Olympus Medical Systems Corporation, 2006) has gone furthest, with 158 descendants of its own.
- 2 other devices also cite its predicate K993041.
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?
This instrument has been designed to be used with an Olymapus video system center, light source, documentation equipment, display monitor, endo-therapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder and urethra.
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/K021074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021074: Visera Cystovideoscope Olympus Cyf Type V/VA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021074
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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