# K142436: 3S Safety Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Sincere Medical Device Co., Ltd.
- Decided: Feb 19, 2015 after 174 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: 5 generations back to K000572 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050131: Insosafe Bak'snap Retractable Insulin Safety Syringe, M.K. Meditech Co., Ltd. (2005) Summary page 4.

## Indications for use
The 3S Safety Insulin Syringe a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

Source page: https://510kreport.com/device/K142436
Methodology: https://510kreport.com/methodology