Cleared Traditional

K981951 - CT 100 ELECTROCARDIOGRAPH

K981951 is an FDA 510(k) clearance for CT 100 ELECTROCARDIOGRAPH, manufactured by Macquarie Medical Systems. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981951 · Macquarie Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
90d
Days
Class 2
Risk

K981951 is an FDA 510(k) clearance for the CT 100 ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Macquarie Medical Systems (Chico, US). The FDA issued a Cleared decision on July 28, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Macquarie Medical Systems devices

FDA 510(k) Submission Details - K981951

510(k) Number K981951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1998
Decision Date July 28, 1998
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 403
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K981951.
CARDIOVISION SOFTWARE, MODEL S-CV5-96
K981807 · Shl Telemedicine International , Ltd. · Aug 1998
ANS 2000 ECG MONITOR AND RESPIRATION PACER
K973426 · D. E. Hokanson, Inc. · Aug 1998
CT 200 ELECTROCARDIOGRAPH
K961798 · Macquarie Medical Systems · Aug 1998
MRI COMPATIBLE MONITOR AND ACCESSORIES
K980362 · Datex-Engstrom, Inc. · Jun 1998
EASY ECG PC BASED ELECTROCARDIOGRAPH
K972996 · Ates Medical S.R.L. · Apr 1998
BIOLOG 3000 ELECTROCARDIOGRAPH
K974351 · Micromedical, Inc. · Apr 1998