510(k) · Cleared
Recalled · Class II · 2022Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary Equipment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Olympus Optical Co. · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Mar 30, 2000 as substantially equivalent to K843084 (Olympus Corp., 1985) and 1 other predicate after a 202-day review. Its family tree reaches back 1 generation to 1985. 5 of the 274 devices in its family, counting itself, have a Class I recall. 271 later devices descend from it. It has been recalled once.
- Decided
- Mar 30, 2000
- Review
- 202 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K843084 (1985). 2 ancestors in all. 271 later devices descend from it, 3 citing it directly. 5 of the 274 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK843084 Olympus CHP-P10 Nephroscope/CystoscopeOlympus Corp. · 1985 · Recalled
- This deviceK993041 Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories…The Olympus Optical Co. · 2000
- Descendant · cites it directly · 268 of its ownK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- Descendant · 2 generations on · 158 of its ownK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- Descendant · 3 generations on · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- Descendant · 2 generations on · 103 of its ownK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- Descendant · 3 generations on · 101 of its ownK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
Showing 5 of 271 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 271 · See all- K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002 · cites it directly268descendants
- K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006 · 2 generations on158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · 3 generations on132descendants
- K030960Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003 · 2 generations on103descendants
- K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004 · 3 generations on101descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843084 | Olympus CHP-P10 Nephroscope/Cystoscope | Olympus Corp. | 1985 | 1 |
| 0 (this device) | K993041 | Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and… | The Olympus Optical Co. | 2000 | — |
| +1 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| +2 | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| +3 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| +2 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| +3 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 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 | 7 | 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.
5 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 |
|---|---|---|---|
| * | K843084 | Olympus CHP-P10 Nephroscope/CystoscopeSummary page 5…ympus XCYF - 1T3 OES Cystofiberscope/Nephrofiberscope Accessories and Ancillary Equipment Cystofiberscope/Nephrofiberscope 21 CFR 876.1500 Endoscopes and Accessories K843084 Olympus Nephroscope/Cystoscope K904940 Infant Resectoscope & Accessories The Olympus XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSC… | 1985 |
| * | K904940 | Olympus Infant Resectoscope and AccessoriesSummary page 5…phrofiberscope Accessories and Ancillary Equipment Cystofiberscope/Nephrofiberscope 21 CFR 876.1500 Endoscopes and Accessories K843084 Olympus Nephroscope/Cystoscope K904940 Infant Resectoscope & Accessories The Olympus XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE has been specifically designed to… | 1992 |
| * | — | Olympus XCYF-113 Named without a submission number | |
| * | — | Olympus Nephroscope/Cystoscope Model CHF-P10 Named without a submission number |
What descends from it? (271)
See all 2713 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2022 | Class II | Z-1262-2022 | Nonconforming Material/Component | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body… |
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.
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 5 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 · 5 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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 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?
These instruments have been designed to be used with an Olympus Light Source, Documentation Equipment, Display Monitor, Suction Pump, Endo—Therapy Accessories, elecrosurgical Unit, and other ancillary equipment for endoscopic diagnosis and treatment within the bladder, urethra, and kidneys.
Do not use this instrument for any purpose other than its intended use.
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/K993041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993041: Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993041
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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