FDA applicant

Mindray DS USA, Inc.

Mahwh, NJ3 decisions2010–20136 recalls

FDA records 3 decisions for Mindray DS USA, Inc. (Mahwh, NJ) from 2010 to 2013: 3 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and BSZ (Gas-Machine, Anesthesia). Its devices cite 5 predicates, 1 of them its own earlier devices. 6 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Mindray DS USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2014

2010high 4 (2012) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Mindray DS USA, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mindray DS USA, Inc.’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 North America 3 Mindray Bio-Medical Electronics Co., Ltd. 2

Mindray DS USA, Inc.

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?

What has been recalled?

Other applicant names beginning “Mindray”