510(k) Report

FDA applicant

Jiangxi Aicare Medical Technology Co., Ltd.

Fuzhou City, CN2 decisions2022–20250 recalls

FDA records 2 decisions for Jiangxi Aicare Medical Technology Co., Ltd. (Fuzhou City, CN) from 2022 to 2025: 2 510(k) clearances. All are in product code DXN (System, Measurement, Blood-Pressure…). 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 Jiangxi Aicare Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

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

Planning a device like Jiangxi Aicare Medical Technology Co.…’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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K250185Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)Jiangxi Aicare Medical Technology Co., Ltd. · 2025
  • K221040Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)Jiangxi Aicare Medical Technology Co., Ltd. · 2022

All 2 as Jiangxi Aicare Medical Technology Co., Ltd. →