FDA applicant

Broadmaster Biotech, Corp.

Taoyuan City, TW4 decisions2011–20190 recalls

FDA records 4 decisions for Broadmaster Biotech, Corp. (Taoyuan City, TW) from 2011 to 2019: 4 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and CGA (Glucose Oxidase, Glucose). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Broadmaster Biotech Corporation”.

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 Broadmaster Biotech, Corp.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2011high 2 (2019) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Broadmaster Biotech, Corp. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Broadmaster Biotech, Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Broadmaster”

FDA records each applicant name separately; these may or may not be the same firm.

Broadmaster Biotech Corperation 1

Broadmaster Biotech, Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Broadmaster”