Cleared Traditional

K973863 - MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR

K973863 is an FDA 510(k) clearance for MEMORYTRACE MODEL 4224 AMBULATORY ECG M..., manufactured by Hi-Tronics Designs, Inc.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K973863 · Hi-Tronics Designs, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
85d
Days
Class 2
Risk

K973863 is an FDA 510(k) clearance for the MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Hi-Tronics Designs, Inc. (Budd Lake, US). The FDA issued a Cleared decision on January 2, 1998 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hi-Tronics Designs, Inc. devices

FDA 510(k) Submission Details - K973863

510(k) Number K973863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1997
Decision Date January 02, 1998
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 135
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K973863.
HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER
K980144 · Aerotel, Ltd. · Jun 1998
CARDIOSTATION
K980624 · Universal Medical, Inc. · May 1998
TTM5000 TELEPHONIC EKG MONITOR
K973267 · Hds Medical, Inc. · Jan 1998
SENTINEL RECORDER, MODELS 471/472
K971696 · Del Mar Avionics · Dec 1997
RHYTHMSTAT XL
K971650 · Data Critical Corp. · Dec 1997
CARDIOCALL CARDIAC EVENT RECORDER
K972649 · Reynolds Medical , Ltd. · Dec 1997