# K961877: Piston Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Univec, Inc.
- Decided: Aug 7, 1996 after 89 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K943679 (1994). 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)
- K943679: Univec Nonresusable Locking Syringe, Univec, Inc. (1994) Summary page 1.

## Indications for use
The UNIVEC Nonreusable Locking Syringe with Coupling Assembly can be used by health care professionals, diabetics and other persons for injection of insulin, tuberculin, immunization serum, and other injectible medications.

Source page: https://510kreport.com/device/K961877
Methodology: https://510kreport.com/methodology