# K971701: Continu-Flo Solution Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jun 6, 1997 after 29 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 K881052 (1988). 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)
- K881052: Check Valve, Baxter Healthcare Corp (1988) Summary page 2.

## Indications for use
Continu-Flo® solution sets with the proposed check valve have the same intended use as the currently marketed sets. The intended use of these sets is the administration of fluids from a container to the patient’s vascular system. Continu-Flo® sets contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication.

Source page: https://510kreport.com/device/K971701
Methodology: https://510kreport.com/methodology