Cleared Traditional

K022078 - SOLA, COUNTER-PULSATION, MODEL SECP-S

K022078 is an FDA 510(k) clearance for SOLA, manufactured by Sola Medical Devices, LLC. The device is a Class 2 Cardiovascular device with product code DRN cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K022078 · Sola Medical Devices, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
198d
Days
Class 2
Risk

K022078 is an FDA 510(k) clearance for the SOLA, COUNTER-PULSATION, MODEL SECP-S. Classified as Device, Counter-pulsating, External (product code DRN), Class II - Special Controls.

Submitted by Sola Medical Devices, LLC (Irvine, US). The FDA issued a Cleared decision on January 10, 2003 after a review of 198 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 - K022078

510(k) Number K022078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2002
Decision Date January 10, 2003
Days to Decision 198 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
73d slower than avg
Panel avg: 125d · This submission: 198d
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 K022078.
CPCA2000 COUNTERPULSATION SYSTEM
K030532 · Cpca2000, Inc. · Mar 2003
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K021340 · External Counterpulsation Lab · Jan 2003
ANGIONEW-IV
K023701 · Living Data Technologies Corporation · Jan 2003
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K023427 · Cardiomedics, Inc. · Jan 2003
NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
K023016 · Nicore Equipment & Leasing, Inc. · Dec 2002
CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000
K022107 · Cardiomedics, Inc. · Aug 2002
K022078 · SOLA, COUNTER-PULSATION, MODEL SECP-S
Download PDF FDA Summary Sola Medical Devices,…