# K231727: Sterile Auto-Disable Syringes with/without Needle for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Wepon Medical Technology Co., Ltd.
- Decided: Sep 8, 2023 after 87 days
- Product code: FMF (Syringe, Piston)
- 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: 4 generations back to K980069 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143497: Safety Auto-Disable Syrine with Needle (Auto-Lock), Guangdong Intmed Medical Appliance Co., Ltd. (2015) Summary page 5.

## Indications for use
The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy.

Source page: https://510kreport.com/device/K231727
Methodology: https://510kreport.com/methodology