Cleared Traditional

K991458 - MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254

K991458 is an FDA 510(k) clearance for MECA WRIST BLOOD PRESSURE METER, manufactured by Matsushita Electric Corp. of America. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 350-day FDA review.

K991458 · Matsushita Electric Corp. of America · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2000
Decision
350d
Days
Class 2
Risk

K991458 is an FDA 510(k) clearance for the MECA WRIST BLOOD PRESSURE METER, MODEL EW243 AND MODEL EW254. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Matsushita Electric Corp. of America (Washington, US). The FDA issued a Cleared decision on April 10, 2000 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Matsushita Electric Corp. of America devices

FDA 510(k) Submission Details - K991458

510(k) Number K991458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date April 10, 2000
Days to Decision 350 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
225d slower than avg
Panel avg: 125d · This submission: 350d
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 846
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