FDA applicant

Biocare Asia Corporation, Ltd.

Suzhou, CN3 decisions2014–20160 recalls

FDA records 3 decisions for Biocare Asia Corporation, Ltd. (Suzhou, CN) from 2014 to 2016: 3 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and DXN (System, Measurement, Blood-Pressure…). Its devices cite 3 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 Biocare Asia Corporation, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Biocare Asia Corporation, Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biocare Asia Corporation, 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 “Biocare”

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

Biocare Corp. 4 Biocare Systems, Inc. 2 Biocare Intl. 1 Biocare Bio-Medical Equipment Co., Ltd. 1

Biocare Asia Corporation, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Biocare”