Cleared Special

K043348 - MODIFICATION TO PM-8000 PATIENT MONITOR

K043348 is the FDA 510(k) clearance for MODIFICATION TO PM-8000 PATIENT MONITOR by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Special 510(k) pathway after a 31-day FDA review.

K043348 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device
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Jan 2005
Decision
31d
Days
Class 2
Risk

K043348 is an FDA 510(k) clearance for the MODIFICATION TO PM-8000 PATIENT MONITOR. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on January 6, 2005 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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. Low regulatory complexity profile. 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 K043348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2004
Decision Date January 06, 2005
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

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