510(k) Report

FDA applicant

Wenzhou Xikang Medical Instruments Co., Ltd.

Wenzhou, CN2 decisions2022–20220 recalls

FDA records 2 decisions for Wenzhou Xikang Medical Instruments Co., Ltd. (Wenzhou, CN) in 2022: 2 510(k) clearances. All are in product code DXQ (Blood Pressure Cuff). 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, cardiovascular panel, where it files most

How often FDA has decided Wenzhou Xikang Medical Instruments Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2022: 2
2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Wenzhou Xikang Medical Instruments Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXQBlood Pressure Cuff2decisions

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.

  • K212416WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope…Wenzhou Xikang Medical Instruments Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K222420Disposable Blood Pressure CuffWenzhou Xikang Medical Instruments Co., Ltd. · 2022
  • K212416WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope…Wenzhou Xikang Medical Instruments Co., Ltd. · 2022

All 2 as Wenzhou Xikang Medical Instruments Co., Ltd. →