# K032247: U.S. Technologies, Inc. Retractable Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Technologies, Inc.
- Decided: Sep 30, 2003 after 70 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 K000572 (2000). 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)
- K003348: E.N.S.I. Retractable Safety Syringe, Ensi-Med International Pty., Ltd. (2001) Summary page 1.
- K000572: E.N.S.I. Syringe, Tri-Ject Intl. Corp. (2000) Summary page 1.

## Indications for use
The U.S. Technologies, Inc., Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety piston syringe which is intended for injection of fluids into the body while reducing the risk of a sharps injury and potential reuse of the syringe.

Source page: https://510kreport.com/device/K032247
Methodology: https://510kreport.com/methodology