# K141640: Automatically Retractable Safety Syringes with Fixed Needle

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Wealy Medical Instrument Co.,Ltd
- Decided: Nov 19, 2014 after 153 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 K970803 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113587: Automatically Retractable Safety Syringe (with Fixed Needle), Shantou Wealy Medical Instrument Co.,Ltd (2012) Summary page 4.

## Most influential descendants
- K222452: Disposable Automatically Retractable Safety Syringes (with detachable needle) (2022), 0 descendants of its own

## Indications for use
Automatically Retractable Safety Syringe with Fixed Needle (1ml, 3ml, 10ml with 30G, 29G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, or 20G) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutancous injection of medication into a patient.

Source page: https://510kreport.com/device/K141640
Methodology: https://510kreport.com/methodology