510(k) Report

FDA applicant

Wenzhou Yosun Medical Technology Co.,Ltd

Wenzhou, CN3 decisions2020–20240 recalls

FDA records 3 decisions for Wenzhou Yosun Medical Technology Co.,Ltd (Wenzhou, CN) from 2020 to 2024: 3 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 207 days from receipt to decision, against 194 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2024

2020: 12023: 12024: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Wenzhou Yosun Medical Technology Co.,Ltd by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FLLContinuous Measurement Thermometer2decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 207 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 194 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K230889Digital ThermometerWenzhou Yosun Medical Technology Co.,Ltd · 2024
  • K231478Digital Blood Pressure Monitor (Model: YB-800)Wenzhou Yosun Medical Technology Co.,Ltd · 2023
  • K201843Infrared ear and forehead thermometer, model YI-100Wenzhou Yosun Medical Technology Co.,Ltd · 2020

All 3 as Wenzhou Yosun Medical Technology Co.,Ltd →