# K042102: Yixin Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Sanxin (Eversincere) Medical Devices Group
- Decided: Mar 8, 2005 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.
4 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has 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.

## Most influential descendants
- K050999: YI Xin Sterile Syringe for Single Use (2005), 3 descendants of its own
- K081436: Invirostripe 3ML, 5ML, 10ML Luer Lock Syringes (2008), 2 descendants of its own
- K101359: Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 and 60 ML) (2010), 1 descendant of its own
- K222744: Sol-M Luer Lock Syringe (2022), 0 descendants of its own

## Indications for use
YI XIN Safety Syringe is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into or withdraw fluids from the body, while reducing the risk of sharps injuries and the potential for syringe reuse. The safety syringes are for IV and IM use.

Source page: https://510kreport.com/device/K042102
Methodology: https://510kreport.com/methodology