# K213077: Automatically Retractable Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Lingyang Medical Apparatus Co., Ltd.
- Decided: Apr 27, 2022 after 216 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Automatically Retractable Safety Syringe is used for aspiration of fluids from vials and ampoules, and a variety of fluid injections into the human body through subcutaneous and muscle. It has a detachable needle with a dedicated fitting. The Automatically Retractable Safety Syringe contains an inner mechanism used to allow the needle to be retracted inside the plunger 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/K213077
Methodology: https://510kreport.com/methodology