# K983994: Unifine

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford USA, Inc.
- Decided: Jan 8, 1999 after 60 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
Longest line of descent: 2 generations back to K941657 (1994). 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)
- K962084: Omnican Syringe, B. Braun Medical AG (1997) Summary page 1.

## Indications for use
The Unifine range of Syringes is designed for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K983994
Methodology: https://510kreport.com/methodology