Cleared Traditional

K002742 - SPHYGMOCOR MX MODEL SCOR-MX

K002742 is the FDA 510(k) clearance for SPHYGMOCOR MX MODEL SCOR-MX by Pwv Medical Pty, Lt.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K002742 · Pwv Medical Pty, Lt. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 25
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K002742.
Endophys Blood Pressure Monitor model BPM-30
K231586 · Endophys Technologies, LLC · Nov 2023
CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box
K152582 · Volcano Corporation · Dec 2015
AS/3 PRESSURE TEMPERATURE MODULE, M-PT
K943457 · Datex Division Instrumentarium Corp. · Jul 1994
AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01
K925899 · Welch Allyn, Inc. · May 1993
A&D TM-2421/2021 AMBULATORY BLOOD PRESSURE MONITOR
K914273 · A&D Engineering, Inc. · Feb 1993
PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE
K912816 · S & W Medico Teknik · Apr 1992