# K143497: Safety Auto-Disable Syrine with Needle (Auto-Lock)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Intmed Medical Appliance Co., Ltd.
- Decided: Nov 4, 2015 after 330 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 K980069 (1998). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132120: WTF Secura Syringe and Needle, Beijing Wantefu Medical Apparatus Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K231727: Sterile Auto-Disable Syringes with/without Needle for Single Use (2023), 0 descendants of its own
- K210229: Sterile Auto-Disable Syringes with/without Needle for Single Use (2022), 0 descendants of its own
- K211210: Sterile Auto-Disable Syringes with/without Needle for Single Use (2022), 0 descendants of its own

## Indications for use
The Safety Auto-Disable Syringe with Needle (Auto-Lock) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy. It has a detachable needle with a dedicated fitting. The Safety Auto-Disable Syringe with Needle (Auto-Lock) contains an inner mechanism used to allow the needle to be retracted inside the plunger rod of the syringe after the operator’s thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.

Source page: https://510kreport.com/device/K143497
Methodology: https://510kreport.com/methodology