510(k) Report

FDA applicant

Jiangxi Yikang Medical Instrument Group Co., Ltd.

Nanchang, CN2 decisions2018–20190 recalls

FDA records 2 decisions for Jiangxi Yikang Medical Instrument Group Co., Ltd. (Nanchang, CN) from 2018 to 2019: 2 510(k) clearances. Most are in product codes EZL (Catheter, Retention Type, Balloon) and BTR (Tube, Tracheal (W/Wo Connector)). Its devices cite 2 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 Yikang Medical Instrument Group Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 12019: 1
2018high 1 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Jiangxi Yikang Medical Instrument Group Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EZLCatheter, Retention Type, Balloon1decision
  • BTRTube, Tracheal (W/Wo Connector)1decision

Whose devices does it build on?

Its devices cite 2 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.

  • K173340Yikang Latex Foley CatheterJiangxi Yikang Medical Instrument Group Co., Ltd. · 20181cites it

What has FDA decided for it lately?

  • K190213Yikang Endotracheal TubeJiangxi Yikang Medical Instrument Group Co., Ltd. · 2019
  • K173340Yikang Latex Foley CatheterJiangxi Yikang Medical Instrument Group Co., Ltd. · 2018

All 2 as Jiangxi Yikang Medical Instrument Group Co., Ltd. →