# K192059: Bio Guard Air/Water & Suction Valves

- Pathway: 510(k) (Special)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Sep 17, 2019 after 47 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K202104: BioGuard EUS Air/Water and Suction Valves (2021), 3 descendants of its own
- 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
- K203630: BioGuard Air/Water and Suction Valves (2021), 0 descendants of its own

## Indications for use
The BioGuard Air/Water Valve is intended to be used to control the air/water function on and endoscope during a GI endoscopic procedure. The BioGuard Suction Valve is intended to be used to control the suction function on and endoscope during a GI endoscopic procedure.

Source page: https://510kreport.com/device/K192059
Methodology: https://510kreport.com/methodology