Cleared Abbreviated

K132075 - PASSPORT M SERIES PATIENT MONITORING (I...

K132075 is an FDA 510(k) clearance for PASSPORT M SERIES PATIENT MONITORING (I..., manufactured by Mindray North America. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Abbreviated 510(k) pathway after a 289-day FDA review.

K132075 · Mindray North America · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2014
Decision
289d
Days
Class 2
Risk

K132075 is an FDA 510(k) clearance for the PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSP.... Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Mindray North America (Mahwh, US). The FDA issued a Cleared decision on April 18, 2014 after a review of 289 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mindray North America devices

FDA 510(k) Submission Details - K132075

510(k) Number K132075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2013
Decision Date April 18, 2014
Days to Decision 289 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 125d · This submission: 289d
Pathway characteristics
Standards-based clearance path.

MHX Device Classification - Class 2, Special Controls

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 338
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