# K031909: Betec Retractable Safety Syringe (5ML)

- Pathway: 510(k) (Traditional)
- Applicant: Betec Medical Science Co., Ltd.
- Decided: Oct 7, 2003 after 109 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 K022278 (2002). 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)
- K022278: TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML), Taiject Medical Device Co., Ltd. (2002)

## Indications for use
The BeTeC Retractable Safety Syringe (5ml) is designed as an anti-stick syringe to aid in the prevention 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 or withdraw from the body.

Source page: https://510kreport.com/device/K031909
Methodology: https://510kreport.com/methodology