510(k) · Cleared
ClearedOlympus Infant Resectoscope and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · FJL Resectoscope
Cleared on Jan 13, 1992 after a 438-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 274 devices in its family, counting itself, have a Class I recall. 273 later devices descend from it.
- Decided
- Jan 13, 1992
- Review
- 438 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 0
273 later devices descend from it, 2 citing it directly. 5 of the 274 devices in this family, counting this one, have a Class I recall.
- This deviceK904940 Olympus Infant Resectoscope and AccessoriesOlympus Corp. · 1992
- Descendant · cites it directly · 271 of its ownK993041 Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories…The Olympus Optical Co. · 2000 · Recalled
- Descendant · 2 generations on · 268 of its ownK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- Descendant · 3 generations on · 158 of its ownK062049 Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006
- Descendant · 4 generations on · 132 of its ownK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- Descendant · 3 generations on · 103 of its ownK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
Showing 5 of 273 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 273 · See all- K993041Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and Ancillary EquipmentThe Olympus Optical Co. · 2000 · cites it directly271descendants
- K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002 · 2 generations on268descendants
- K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations on158descendants
- K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · 4 generations on132descendants
- K030960Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003 · 3 generations on103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904940 | Olympus Infant Resectoscope and Accessories | Olympus Corp. | 1992 | — |
| +1 | K993041 | Olympus Xcyf-1T3 Oes Cystofiberscope/Nephrofiberscope Accessories and… | The Olympus Optical Co. | 2000 | 1 |
| +2 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| +3 | K062049 | Evis Exera II 180 System | Olympus Medical Systems Corporation | 2006 | — |
| +4 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| +3 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 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), 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 FJL device
- #1 K221893 KARL STORZ Bipolar Resectoscopes with HF Cablescore 7.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (273)
See all 2732 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)
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.
- K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 18 Class I recalls
- K183419EVIS EXERA III Bronchovideoscope Olympus BF-XT190Olympus Medical Systems Corp. · 2019 · 6 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 · 6 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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K993041 (The Olympus Optical Co., 2000) has gone furthest, with 271 descendants of its own.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FJL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FJL
Too few FJL 510(k)s in any year since 2007 to give a median.
Recalls per year · FJL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FJL
67in 2025
MAUDE reports naming product code FJL, 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 | 1 | — | 0 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 15 |
| 2010 | 1 | — | 0 | 34 |
| 2011 | 0 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 1 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 50 |
| 2019 | 2 | — | 0 | 53 |
| 2020 | 0 | — | 0 | 55 |
| 2021 | 0 | — | 0 | 54 |
| 2022 | 0 | — | 1 | 74 |
| 2023 | 2 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 67 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K904940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K904940: Olympus Infant Resectoscope 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/K904940
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026