# K050999: YI Xin Sterile Syringe for Single Use

- Pathway: 510(k) (Traditional)
- Applicant: Jiangxi Sanxin (Eversincere) Medical Devices Group
- Decided: Sep 2, 2005 after 135 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042102 (2005). 1 ancestor in all.
3 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)
- K042102: Yixin Safety Syringe, Jiangxi Sanxin (Eversincere) Medical Devices Group (2005) Summary page 3.

## Most influential descendants
- 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

## Recalls of this device
- Aug 8, 2023 · Class I · Z-0005-2024: There is a potential for blood backfill leakage and foreign material.
- Aug 8, 2023 · Class I · Z-0006-2024: There is a potential for blood backfill leakage and foreign material.
- Aug 8, 2023 · Class I · Z-0007-2024: There is a potential for blood backfill leakage and foreign material.

## Indications for use
YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K050999
Methodology: https://510kreport.com/methodology