# K202104: BioGuard EUS Air/Water and Suction Valves

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jan 14, 2021 after 169 days
- Product code: ODC (Endoscope Channel Accessory)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K192059 (2019). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192059: Bio Guard Air/Water & Suction Valves, United States Endoscopy Group, Inc. (2019) Summary page 5.

## Most influential descendants
- K240098: DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (2024), 1 descendant of its own
- K250949: Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (2025), 0 descendants of its own
- K242742: DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K202104
Methodology: https://510kreport.com/methodology