FDA applicant

Mindray Bio-Medical Electronics Co., Ltd.

Nanshan, CN2 decisions2015–20160 recalls

FDA records 2 decisions for Mindray Bio-Medical Electronics Co., Ltd. (Nanshan, CN) from 2015 to 2016: 2 510(k) clearances. All are in product code GKZ (Counter, Differential Cell). Its devices cite 2 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, hematology panel, where it files most

How often FDA has decided Mindray Bio-Medical Electronics Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Mindray Bio-Medical Electronics Co., Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mindray Bio-Medical Electronics 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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Other applicant names beginning “Mindray”

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

Mindray DS USA, Inc. 3 Mindray North America 3

Mindray Bio-Medical Electronics Co., 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 “Mindray”