# K881052: Check Valve

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: May 26, 1988 after 76 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K971701: Continu-Flo Solution Set (1997), 0 descendants of its own

## Recalls of this device
- Jul 16, 2003 · Not classified · Z-1151-03: There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.

Source page: https://510kreport.com/device/K881052
Methodology: https://510kreport.com/methodology