510(k) Report

FDA applicant

Cardicare Company, Ltd.

Hangzhou City, CN2 decisions2008–20220 recalls

FDA records 2 decisions for Cardicare Company, Ltd. (Hangzhou City, CN) from 2008 to 2022: 2 510(k) clearances. All are in product code DXQ (Blood Pressure Cuff). Its devices cite 2 predicates, 1 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 Cardicare Company, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2008: 12022: 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 — Cardicare Company, 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 Cuff2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K082542Aneroid Sphygmomanometer with Stethoscope Model HBPK-aCardicare Company, Ltd. · 20081cites it

What has FDA decided for it lately?

  • K222652Aneroid Sphygmomanometer; Single Patient Use Aneroid SphygmomanometerCardicare Company, Ltd. · 2022
  • K082542Aneroid Sphygmomanometer with Stethoscope Model HBPK-aCardicare Company, Ltd. · 2008

All 2 as Cardicare Company, Ltd. →