Cleared Traditional

K070791 - PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS

K070791 is an FDA 510(k) clearance for PM SERIES PATIENT MONITORS, manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K070791 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device
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Jun 2007
Decision
96d
Days
Class 2
Risk

K070791 is an FDA 510(k) clearance for the PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on June 26, 2007 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K070791

510(k) Number K070791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2007
Decision Date June 26, 2007
Days to Decision 96 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 398
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K070791.
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