# K142435: 3S Safety Syringe with/without Needle

- Pathway: 510(k) (Traditional)
- Applicant: Sincere Medical Device Co., Ltd.
- Decided: Feb 20, 2015 after 175 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 K040545 (2004). 1 ancestor in all.
2 later devices descend 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)
- K040545: Otter Safety Syringe, Otter (China) Technology Co., Ltd. (2004) Summary page 4.

## Most influential descendants
- K152606: Jeesung Safety Syringe and Single Use Needles (2016), 1 descendant of its own
- K212518: Jeesung Safety Syringe and Single Use Needles (2022), 0 descendants of its own

## Indications for use
The 3S Safety Syringe with/without Needle is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.

Source page: https://510kreport.com/device/K142435
Methodology: https://510kreport.com/methodology