510(k) · Cleared
ClearedBioGuard EUS Air/Water and Suction Valves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · ODC Endoscope Channel Accessory
Cleared on Jan 14, 2021 as substantially equivalent to K192059 (United States Endoscopy Group, Inc., 2019) after a 169-day review. Its family tree reaches back 1 generation to 2019. 3 later devices descend from it.
- Decided
- Jan 14, 2021
- Review
- 169 days
- Class
- Class II
- Product code
- ODC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K192059 (2019). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK192059 Bio Guard Air/Water & Suction ValvesUnited States Endoscopy Group, Inc. · 2019
- This deviceK202104 BioGuard EUS Air/Water and Suction ValvesSTERIS Corporation · 2021
- Descendant · cites it directly · 1 of its ownK240098 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS…STERIS Corporation · 2024
- Descendant · cites it directly · 0 of its ownK250949 Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK242742 DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS…STERIS Corporation · 2024
Most influential descendants
Showing 3 of 3 · See all- K240098DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)STERIS Corporation · 2024 · cites it directly1descendant
- K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
- K242742DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)STERIS Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K192059 | Bio Guard Air/Water & Suction Valves | United States Endoscopy Group, Inc. | 2019 | — |
| 0 (this device) | K202104 | BioGuard EUS Air/Water and Suction Valves | STERIS Corporation | 2021 | — |
| +1 | K240098 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | 2024 | — |
| +1 | K250949 | Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) | Olympus Medical Systems Corporation | 2025 | 2 |
| +2 | K242742 | DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) | STERIS Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 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.
Planning a device in ODC? 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 ODC device
- #1 K232329 Defendo Fujifilm 700 Single Use Biopsy Valve…score 14.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K192059 | Bio Guard Air/Water & Suction ValvesSummary page 5…y (ODC) Colonoscope and Accessories, Flexible, Rigid (FDF) 3. Predicate Device K192059 BioGuard Air/Water Valve, BioGuard Suction Valve 4. Description of Device The BioGuard EUS Air/Wate… | 2019 |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All ODC devicesODC Endoscope Channel Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · ODC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODC
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODC
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODC
91in 2025
MAUDE reports naming product code ODC, 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 | 0 | — | 0 | 0 |
| 2008 | 3 | 83 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 67 | 0 | 0 |
| 2011 | 4 | 143 | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 4 | 55 | 0 | 40 |
| 2020 | 4 | 128 | 0 | 54 |
| 2021 | 6 | 181 | 0 | 52 |
| 2022 | 8 | 118 | 0 | 37 |
| 2023 | 7 | 126 | 0 | 43 |
| 2024 | 8 | 95 | 0 | 100 |
| 2025 | 6 | 106 | 0 | 91 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The BioGuard EUS AH/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The BioGuard EUS Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202104: BioGuard EUS Air/Water and Suction Valves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202104
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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