# K990288: Free Flow Safety Device, Model MG 245052

- Pathway: 510(k) (Traditional)
- Applicant: Teva Medical, Ltd.
- Decided: Feb 24, 1999 after 26 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
For use with any L.V. set assembled on commercially available 1.V. pumps (not equipped with free flow protection), in order to prevent free flow of drugs or L.V. fluids.

Source page: https://510kreport.com/device/K990288
Methodology: https://510kreport.com/methodology