Cleared Traditional

AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE (K012141) - FDA 510(k) Clearance

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

K012141 · External Counterpulsation Lab · Cardiovascular device
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Oct 2001
Decision
107d
Days
Class 2
Risk

K012141 is an FDA 510(k) clearance for the AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by External Counterpulsation Lab (Kfar Saba, IL). The FDA issued a Cleared decision on October 25, 2001 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5225 - 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 External Counterpulsation Lab devices

Submission Details

510(k) Number K012141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2001
Decision Date October 25, 2001
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRN Device, Counter-pulsating, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5225
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.