Cleared Traditional

SPHYGMOCOR MX MODEL SCOR-MX (K002742) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002742 · Pwv Medical Pty, Lt. · Cardiovascular device
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May 2001
Decision
242d
Days
Class 2
Risk

K002742 is an FDA 510(k) clearance for the SPHYGMOCOR MX MODEL SCOR-MX. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Pwv Medical Pty, Lt. (Rockville, US). The FDA issued a Cleared decision on May 1, 2001 after a review of 242 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 Pwv Medical Pty, Lt. devices

Submission Details

510(k) Number K002742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2000
Decision Date May 01, 2001
Days to Decision 242 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
117d slower than avg
Panel avg: 125d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 76
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K002742.
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CARDIAC OUTPUT COMPUTER MODEL 701
K771977 · Instrumentation Laboratory CO · Jan 1978