Cleared Traditional

K973640 - TS2000 MEDICAL DEVICE MONITOR

K973640 is an FDA 510(k) clearance for TS2000 MEDICAL DEVICE MONITOR, manufactured by Trincore Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MSX cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K973640 · Trincore Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
169d
Days
Class 2
Risk

K973640 is an FDA 510(k) clearance for the TS2000 MEDICAL DEVICE MONITOR. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Trincore Systems, Inc. (Fort Worth, US). The FDA issued a Cleared decision on March 12, 1998 after a review of 169 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Trincore Systems, Inc. devices

FDA 510(k) Submission Details - K973640

510(k) Number K973640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1997
Decision Date March 12, 1998
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSX Device Classification - Class 2, Special Controls

Product Code MSX System, Network And Communication, Physiological Monitors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MSX System, Network And Communication, Physiological Monitors

All 81
Devices cleared under the same product code (MSX) and FDA review panel - the closest regulatory comparables to K973640.
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CARDIO-PAGER SYSTEM
K973527 · Data Critical Corp. · Mar 1998
MOBIMED SYSTEM, (PEGASUS AND POLARIS)
K973318 · Ortivus Us, Inc. · Feb 1998
DATEX-ENGSTROM NETWORK
K974101 · Datex-Engstrom, Inc. · Feb 1998
HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER
K974567 · Hewlett-Packard Co. · Jan 1998