Cleared Special

K072346 - PM-7000 PATIENT MONITOR

K072346 is the FDA 510(k) clearance for PM-7000 PATIENT MONITOR by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Special 510(k) pathway after a 100-day FDA review.

K072346 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device
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Nov 2007
Decision
100d
Days
Class 2
Risk

K072346 is an FDA 510(k) clearance for the PM-7000 PATIENT MONITOR. 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 November 29, 2007 after a review of 100 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

Submission Details

510(k) Number K072346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2007
Decision Date November 29, 2007
Days to Decision 100 days
Submission Type Special
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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 274
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