Cleared Traditional

MEMORYTRACE ATM MODEL 4222 (K941898) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941898 · Hi-Tronics Designs, Inc. · Cardiovascular device
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Jun 1995
Decision
434d
Days
Class 2
Risk

K941898 is an FDA 510(k) clearance for the MEMORYTRACE ATM MODEL 4222. 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 June 26, 1995 after a review of 434 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Hi-Tronics Designs, Inc. devices

Submission Details

510(k) Number K941898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1994
Decision Date June 26, 1995
Days to Decision 434 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 125d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K941898.
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MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR
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K913533 · Hewlett-Packard Co. · Nov 1991
MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
K912084 · Medtronic Vascular · Jul 1991