# K011888: Pressure Activated Check Valve

- Pathway: 510(k) (Traditional)
- Applicant: Churchill Medical Systems, Inc.
- Decided: Sep 10, 2001 after 84 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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 K984441 (1999). 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)
- K984441: Kvo Check Valve Accessory, Model EV-0001, I-Flow Corp. (1999) Summary page 1.

## Indications for use
Accessory device used to allow pressurized fluid flow in one direction and stop, or check flow in the opposite direction.

Source page: https://510kreport.com/device/K011888
Methodology: https://510kreport.com/methodology