# K141349: Disposable sterile needle retractable safety syringe

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Haiou Medical Apparatus Stock Co., Ltd.
- Decided: Apr 10, 2015 after 323 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
Disposable sterile needle retractable safety syringe 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 subcutaneous injection of medication into patient.

Source page: https://510kreport.com/device/K141349
Methodology: https://510kreport.com/methodology