510(k) · Cleared
Recalled · Class II · 2019Olympus Disposable Suction Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Mar 24, 1992 after an 81-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 24, 1992
- Review
- 81 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK920025 Olympus Disposable Suction ValveOlympus Corp. · 1992
- Descendant · cites it directly · 0 of its ownK151714 Disposable Endoscope Valves Set AWilson Instruments (Shanghai) Company Limited · 2015
- Descendant · cites it directly · 0 of its ownK151522 DEFENDO Bronchoscopy Suction ValveMedivators, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920025 | Olympus Disposable Suction Valve | Olympus Corp. | 1992 | — |
| +1 | K151714 | Disposable Endoscope Valves Set A | Wilson Instruments (Shanghai) Company Limited | 2015 | — |
| +1 | K151522 | DEFENDO Bronchoscopy Suction Valve | Medivators, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 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.
Planning a device in EOQ? 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 EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2019 | Class II | Z-2148-2019 | Process control | There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151714 (Wilson Instruments (Shanghai) Company Limited, 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
https://510kreport.com/device/K920025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920025: Olympus Disposable Suction Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920025
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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