Cleared Traditional

K033894 - PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032

K033894 is an FDA 510(k) clearance for PANASONIC WRIST BLOOD PRESSURE MONITOR, manufactured by Matsushita Electric Works, Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K033894 · Matsushita Electric Works, Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
86d
Days
Class 2
Risk

K033894 is an FDA 510(k) clearance for the PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032. 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 March 11, 2004 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Matsushita Electric Works, Ltd. devices

FDA 510(k) Submission Details - K033894

510(k) Number K033894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2003
Decision Date March 11, 2004
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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 847
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