510(k) Report

FDA applicant

Guangzhou Berrcom Medical Device Co., Ltd.

Guangzhou, CN6 decisions2019–20230 recalls

FDA records 6 decisions for Guangzhou Berrcom Medical Device Co., Ltd. (Guangzhou, CN) from 2019 to 2023: 6 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 151 days from receipt to decision, against 218 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 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 Guangzhou Berrcom Medical Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019: 12022: 42023: 1
2019high 4 (2022) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Guangzhou Berrcom Medical Device Co., Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Guangzhou Berrcom Medical Device 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?

  • FLLContinuous Measurement Thermometer6decisions

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 151 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 218 days; 5 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 20196cite it

What has FDA decided for it lately?

  • K214077Digital Thermometer, Model: DT007, DT008Guangzhou Berrcom Medical Device Co., Ltd. · 2023
  • K213746Digital thermometer, Model DT101, DT102Guangzhou Berrcom Medical Device Co., Ltd. · 2022
  • K213084Ear Thermometer, Model ET005, ET008, ET009Guangzhou Berrcom Medical Device Co., Ltd. · 2022
  • K213079Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd. · 2022
  • K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311Guangzhou Berrcom Medical Device Co., Ltd. · 2022
  • K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019

All 6 as Guangzhou Berrcom Medical Device Co., Ltd. →