# K031394: American Syringe Company 1CC and 3CC Syringe

- Pathway: 510(k) (Traditional)
- Applicant: American Syringe Company
- Decided: Jul 25, 2003 after 84 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The American Syringe Company 3cc Syringe is indicated for use in the injection of medication into a patient.

Source page: https://510kreport.com/device/K031394
Methodology: https://510kreport.com/methodology