Cleared Traditional

K021340 - AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE

K021340 is an FDA 510(k) clearance for AECP-A, manufactured by External Counterpulsation Lab. The device is a Class 2 Cardiovascular device with product code DRN cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K021340 · External Counterpulsation Lab · Cardiovascular device
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Jan 2003
Decision
279d
Days
Class 2
Risk

K021340 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 (Shanghai, CN). The FDA issued a Cleared decision on January 30, 2003 after a review of 279 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K021340

510(k) Number K021340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2002
Decision Date January 30, 2003
Days to Decision 279 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
154d slower than avg
Panel avg: 125d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DRN Device, Counter-pulsating, External

All 31
Devices cleared under the same product code (DRN) and FDA review panel - the closest regulatory comparables to K021340.
MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
K033657 · Living Data Technologies Corporation · Dec 2003
EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP
K030587 · S-Tct Health, Inc. · May 2003
CPCA2000 COUNTERPULSATION SYSTEM
K030532 · Cpca2000, Inc. · Mar 2003
ANGIONEW-IV
K023701 · Living Data Technologies Corporation · Jan 2003
SOLA, COUNTER-PULSATION, MODEL SECP-S
K022078 · Sola Medical Devices, LLC · Jan 2003
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K023427 · Cardiomedics, Inc. · Jan 2003
K021340 · AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
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