510(k) Report

FDA applicant

Wenzhou Kindcare Import & Export Co., Ltd.

Flintville, TN1 decision2008–20080 recalls

FDA records 1 decision for Wenzhou Kindcare Import & Export Co., Ltd. (Flintville, TN) in 2008: 1 510(k) clearance. All are in product code DXQ (Blood Pressure Cuff). 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 Kindcare Import & Export Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Wenzhou Kindcare Import & Export Co., Ltd. by year, 2008–2026Sources: 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 Cuff1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K081951Aneroid Sphygmomanometer, Model KT-A01Wenzhou Kindcare Import & Export Co., Ltd. · 20082cite it

What has FDA decided for it lately?

  • K081951Aneroid Sphygmomanometer, Model KT-A01Wenzhou Kindcare Import & Export Co., Ltd. · 2008

The one decision as Wenzhou Kindcare Import & Export Co., Ltd. →