# K191559: AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM

- Pathway: 510(k) (Special)
- Applicant: United States Endoscopy Group, Inc.
- Decided: Aug 1, 2019 after 49 days
- Product code: FEQ (Pump, Air, Non-Manual, For Endoscope)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K222734: Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing (2022), 0 descendants of its own

## Indications for use
The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available water bottles.

Source page: https://510kreport.com/device/K191559
Methodology: https://510kreport.com/methodology