# K031065: Syringex Safety Syringe, Model 0322G1.5

- Pathway: 510(k) (Traditional)
- Applicant: Syringex Medical, Inc.
- Decided: Jun 23, 2003 after 81 days
- Product code: MEG (Syringe, Antistick)
- 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: 1 generation back to K910520 (1991). 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)
- K925039: Safesnap Safety Syringe, U.S. Medical Instruments, Inc. (1994) Summary page 1.
- K910520: Safetysnap Safety Syringe, U.S. Medical Instruments, Inc. (1991) Summary page 1.

## Indications for use
The primary intended use of the Syringex Safety SyringeO is “a hypodermic needle and syringe intended to inject fluid into or withdraw fluid from the body”. The secondary intended use is that the sharps safety feature will help to reduce the number of sharps injuries by providing an immediate and mandatory elimination of the sharp by its safe, simple and easy retraction into the barrel of the syringe. The feature will help prevent sharps injuries when using the device for its primary intended use.

Source page: https://510kreport.com/device/K031065
Methodology: https://510kreport.com/methodology