Cleared Traditional

MODEL 4222 AMBULATORY ECG MONITOR (K904250) - FDA 510(k) Clearance

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

K904250 · Byrncrest Global, Inc. · Cardiovascular device
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Feb 1991
Decision
161d
Days
Class 2
Risk

K904250 is an FDA 510(k) clearance for the MODEL 4222 AMBULATORY ECG MONITOR. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Byrncrest Global, Inc. (West Columbia, US). The FDA issued a Cleared decision on February 25, 1991 after a review of 161 days - an extended review 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: 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 Byrncrest Global, Inc. devices

Submission Details

510(k) Number K904250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1990
Decision Date February 25, 1991
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
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 K904250.
MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR
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MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
K912084 · Medtronic Vascular · Jul 1991
MODEL 9444 TELETRACE II ECG MONITORING SYSTEM
K903960 · Medtronic Vascular · Oct 1990
MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING
K893471 · Medtronic Vascular · Sep 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · Hewlett-Packard Co. · Sep 1989