510(k) Report

FDA applicant

Jiangxi Sanxin (Eversincere) Medical Devices Group

Nan Chang, Jiangxi, CN2 decisions2005–20053 recalls

FDA records 2 decisions for Jiangxi Sanxin (Eversincere) Medical Devices Group (Nan Chang, Jiangxi, CN) in 2005: 2 510(k) clearances. Most are in product codes MEG (Syringe, Antistick) and FMF (Syringe, Piston). Its devices cite 1 predicate, 1 of them its own earlier devices. 3 recalls are linked to its devices, 3 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Jiangxi Sanxin (Eversincere) Medical Devices Group’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jiangxi Sanxin (Eversincere) Medical Devices Group since 2007.

Recalls per year

3in 2023

2023: 3, 3 Class I
2007high 3 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Jiangxi Sanxin (Eversincere) Medical Devices Group by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MEGSyringe, Antistick1decision
  • FMFSyringe, Piston1decision

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K042102Yixin Safety SyringeJiangxi Sanxin (Eversincere) Medical Devices Group · 20051cites it
  • K050999YI Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group · 20051cites it

What has FDA decided for it lately?

  • K050999YI Xin Sterile Syringe for Single UseJiangxi Sanxin (Eversincere) Medical Devices Group · 20053 Class I recalls
  • K042102Yixin Safety SyringeJiangxi Sanxin (Eversincere) Medical Devices Group · 2005

All 2 as Jiangxi Sanxin (Eversincere) Medical Devices Group →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K05099910ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a…Aug 8, 2023Class I
  • K05099910ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per caseAug 8, 2023Class I
  • K0509993ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes…Aug 8, 2023Class I