Cleared Special

K042818 - PANASONIC WRIST BLOOD PRESSURE MONITOR

K042818 is the FDA 510(k) clearance for PANASONIC WRIST BLOOD PRESSURE MONITOR by Matsushita Electric Works, Ltd.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 107-day FDA review.

K042818 · Matsushita Electric Works, Ltd. · Cardiovascular device
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Jan 2005
Decision
107d
Days
Class 2
Risk

K042818 is an FDA 510(k) clearance for the PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW3003 AND EW3037. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Matsushita Electric Works, Ltd. (Great Neck, US). The FDA issued a Cleared decision on January 27, 2005 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Matsushita Electric Works, Ltd. devices

Submission Details

510(k) Number K042818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date January 27, 2005
Days to Decision 107 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 520
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