FDA applicant

Fudakang Industries Co., Ltd.

Shenzhen, Guangdong, CN2 decisions2010–20160 recalls

FDA records 2 decisions for Fudakang Industries Co., Ltd. (Shenzhen, Guangdong, CN) from 2010 to 2016: 2 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). 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 Fudakang Industries Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Fudakang Industries Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fudakang Industries Co., Ltd.’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 “Fudakang”

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

Fudakang Industrial Co., Ltd. 4

Fudakang Industries Co., Ltd.

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 “Fudakang”