# K203630: BioGuard Air/Water and Suction Valves

- Pathway: 510(k) (Special)
- Applicant: Steris Corporations
- Decided: Jan 8, 2021 after 28 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The BioGuard Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure. The BioGuard 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/K203630
Methodology: https://510kreport.com/methodology