Cleared Traditional

K221321 - MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System (FDA 510(k) Clearance)

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

K221321 · Ge Medical Systems Information Technologies, Inc. · Cardiovascular device

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Oct 2022

Decision

165d

Days

Class 2

Risk

K221321 is an FDA 510(k) clearance for the MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies, Inc. (Wauwatosa, US). The FDA issued a Cleared decision on October 18, 2022 after a review of 165 days - an extended review cycle.

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 Ge Medical Systems Information Technologies, Inc. devices

Submission Details

510(k) Number	K221321 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 06, 2022
Decision Date	October 18, 2022
Days to Decision	165 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

40d slower than avg

Panel avg: 125d · This submission: 165d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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.