Cleared Traditional

K973637 - PRESS-MATE ADVANTAGE

K973637 is an FDA 510(k) clearance for PRESS-MATE ADVANTAGE, manufactured by Colin Medical Instruments Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K973637 · Colin Medical Instruments Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
366d
Days
Class 2
Risk

K973637 is an FDA 510(k) clearance for the PRESS-MATE ADVANTAGE. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Colin Medical Instruments Corp. (San Antonio, US). The FDA issued a Cleared decision on September 25, 1998 after a review of 366 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 Colin Medical Instruments Corp. devices

FDA 510(k) Submission Details - K973637

510(k) Number K973637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1997
Decision Date September 25, 1998
Days to Decision 366 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
241d slower than avg
Panel avg: 125d · This submission: 366d
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 767
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K973637.
6004 NIBP MONITOR WITH TEMPERATURE
K983796 · Bci Intl., Inc. · Jan 1999
MS-900S, MS-900SPM & MS-900SFM
K980845 · Mars Medical Products · Dec 1998
FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F
K983855 · Jawon Medical Co., Ltd. · Nov 1998
A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR
K982481 · A&D Engineering, Inc. · Sep 1998
OSCILLOMATE EMS NIBP MONITOR MODEL 9001
K982135 · Cas Medical Systems, Inc. · Sep 1998
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000
K964153 · Rossmax International , Ltd. · Jun 1998