# K113587: Automatically Retractable Safety Syringe (with Fixed Needle)

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Wealy Medical Instrument Co.,Ltd
- Decided: Feb 24, 2012 after 81 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: 1 generation back to K970803 (1997). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970803: Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint Syringe, Retractable Technologies, Inc. (1997) Summary page 2.

## Most influential descendants
- K141640: Automatically Retractable Safety Syringes with Fixed Needle (2014), 1 descendant of its own
- K222452: Disposable Automatically Retractable Safety Syringes (with detachable needle) (2022), 0 descendants of its own
- K141349: Disposable sterile needle retractable safety syringe (2015), 0 descendants of its own

## Indications for use
Automatically Retractable Safety Syringe (with fixed needle) (5cc/mi 22x1-1/4) 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 a patient.

Source page: https://510kreport.com/device/K113587
Methodology: https://510kreport.com/methodology