# K983217: Rowe Dual-Check Valve

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Jan 20, 1999 after 128 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 K790062 (1979). 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)
- K790062: IV Administration Set with Backcheck, National Patent Development Corp. (1979) Summary page 1.
- (no number) Dual Check Valve marketed by Burron: named in the summary without a submission number

## Indications for use
The Rowe Dual-Check Valve device is intended for use with IV cannula or extension tube sets for simultaneous or alternate administration of IV drugs and fluids. The check valve is used in conjunction with a standard Luer taper syringe.

Source page: https://510kreport.com/device/K983217
Methodology: https://510kreport.com/methodology