# K972728: Sterile Water for Injection Prefilled Syring (Swfips)

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Jul 15, 1998 after 359 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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. The FDA summary names its predicate without a number.
- (no number) BD® GLASPAK® syringe: named in the summary without a submission number

## Indications for use
SWFIPS is a combination product intended to be used by patients, pharmacists or physicians for the reconstitution and administration of approved prescription drug products. SWFIPS is not labeled or intended for stand alone use. The indications for use of the reconstituted drug or biologic are contained in the package insert for each product.

Source page: https://510kreport.com/device/K972728
Methodology: https://510kreport.com/methodology