510(k) Report

FDA applicant

Xiamen Ants Bro Technology Co., Ltd.

Xiamen, CN3 decisions2019–20200 recalls

FDA records 3 decisions for Xiamen Ants Bro Technology Co., Ltd. (Xiamen, CN) from 2019 to 2020: 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 373 days from receipt to decision, against 198 for FDA’s reviews in the same codes and years. Its devices cite 4 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, general hospital panel, where it files most

How often FDA has decided Xiamen Ants Bro Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2019: 12020: 2
2019high 2 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Xiamen Ants Bro Technology Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xiamen Ants Bro Technology Co., Ltd.’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?

  • 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 373 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 198 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 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.

  • K190990Digital ThermometerXiamen Ants Bro Technology Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K190982Automatic Digital Blood Pressure MonitorXiamen Ants Bro Technology Co., Ltd. · 2020
  • K190984Infrared Forehead ThermometerXiamen Ants Bro Technology Co., Ltd. · 2020
  • K190990Digital ThermometerXiamen Ants Bro Technology Co., Ltd. · 2019

All 3 as Xiamen Ants Bro Technology Co., Ltd. →