510(k) Report

FDA applicant

Jiangxi Sanxin Medtec Co., Ltd.

Nanchang, CN3 decisions2015–20210 recalls

FDA records 3 decisions for Jiangxi Sanxin Medtec Co., Ltd. (Nanchang, CN) from 2015 to 2021: 3 510(k) clearances. Most are in product codes FJK (Set, Tubing, Blood, With And Without…) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Jiangxi Sanxin Medtec Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2015: 12021: 2
2015high 2 (2021) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Jiangxi Sanxin Medtec Co., Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jiangxi Sanxin Medtec Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • FXXMask, Surgical1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd. · 20211cites it

What has FDA decided for it lately?

  • K202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd. · 2021
  • K202719Disposable Medical Face MasksJiangxi Sanxin Medtec Co., Ltd. · 2021
  • K142797I.V. CatheterJiangxi Sanxin Medtec Co., Ltd. · 2015

All 3 as Jiangxi Sanxin Medtec Co., Ltd. →