510(k) Report

FDA applicant

Mindray North America

Mahwh, NJ3 decisions2014–20142 recalls

FDA records 3 decisions for Mindray North America (Mahwh, NJ) in 2014: 3 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and MHX (Monitor, Physiological, Patient (With…). Its devices cite 6 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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 North America’s devices, and how often a recall has named them.

FDA decisions per year

3in 2014

2014: 3
2014high 3 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

2in 2019

2019: 2
2014high 2 (2019) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Mindray North America by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2decisions
  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America · 20142cite it
  • K132037Vital Signs MonitorMindray North America · 20142cite it
  • K132038Accutorr 7 Vital Signs MonitorMindray North America · 20141cites it

What has FDA decided for it lately?

  • K132037Vital Signs MonitorMindray North America · 20142 recalls
  • K132038Accutorr 7 Vital Signs MonitorMindray North America · 2014
  • K132075Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M)Mindray North America · 2014

All 3 as Mindray North America →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K132037Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00…Oct 1, 2019Class II
  • K132037Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00…Oct 1, 2019Class II

Other applicant names beginning “Mindray”

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

Mindray DS USA, Inc. 3Mindray Bio-Medical Electronics Co., Ltd. 2