# K970736: Braun Prefilled Syringe

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Dec 16, 1998 after 656 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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 K760392 (1976). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760392: Syringes, B. Braun Instruments (1976) Summary page 1.
- K952645: Vital Signs Saline Vascular Access Flush Device, Vital Signs, Inc. (1995) Summary page 2.
- (no number) Solopak™ 0.9% Sodium Chloride: named in the summary without a submission number

## Indications for use
The Normal Saline prefilled syringes are indicated solely for use in flushing intravascular catheters and maintaining the patency of indwelling intravascular catheters.

Source page: https://510kreport.com/device/K970736
Methodology: https://510kreport.com/methodology