Cleared Traditional

K904298 - EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR

K904298 is the FDA 510(k) clearance for EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR by Medi-Swiss Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K904298 · Medi-Swiss Corp. · Cardiovascular device
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Jun 1991
Decision
275d
Days
Class 2
Risk

K904298 is an FDA 510(k) clearance for the EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Medi-Swiss Corp. (Oradell, US). The FDA issued a Cleared decision on June 21, 1991 after a review of 275 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Medi-Swiss Corp. devices

Submission Details

510(k) Number K904298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1990
Decision Date June 21, 1991
Days to Decision 275 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 125d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 544
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K904298.
DIGITAL SPHYGMOMANOMETER MODEL UA-833
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CARDIOCAP CMX-104 MONITOR
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K911310 · Ge Medical Systems Information Technologies · Jun 1991
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
K903771 · Hewlett-Packard Co. · Feb 1991
LOCAL REPORT GENERATOR
K904318 · Spacelabs, Inc. · Dec 1990