# K050116: Uniqsafe Rotatable, Retractable Safety Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Uniqsafe Biomeditech Co., Ltd.
- Decided: May 9, 2005 after 111 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: 2 generations back to K011754 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040545: Otter Safety Syringe, Otter (China) Technology Co., Ltd. (2004) Summary page 1.
- K031163: Sez Safety Syringe, Sez Corporation (2003) Summary page 1.

## Indications for use
The UNIQSAFE Rotatable, Retractable Safety Syringe (lml, 3ml, 5ml, 10ml) is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe reuse and is a single use, -disposable and manual retractable safety syringe which is intended for injection of medical fluids into the body.

Source page: https://510kreport.com/device/K050116
Methodology: https://510kreport.com/methodology