# K121637: Auto-Disable Sterile Safty Syring for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Sunwell Biotech Co., Ltd.
- Decided: Oct 25, 2012 after 143 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: 3 generations back to K941450 (1994). 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)
- K092430: 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock Safety Syringes, Inviro Medical Devices, Inc. (2009) Summary page 1.

## Indications for use
The Auto-Disable Sterile Safety Syringe for Single Use 5mL, is used to inject fluids into, or withdraw fluids from the body. In addition, the retractable needle of the syringe goes into the barrel after use. It is designed to aid in the prevention of needle stick injuries.

Source page: https://510kreport.com/device/K121637
Methodology: https://510kreport.com/methodology