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Sola Counter-Pulsation, Model SECP-S

by Sola Medical Devices, LLC

510(k) K022078

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022078 Date10 Jan 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRN
Device Class
Class II
Regulation
21 CFR Part 870.5225
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Sola Counter-Pulsation, Model SECP-S is an external counter-pulsation device classified as a Class II medical device. It is designed to augment peripheral blood flow by synchronizing cuff inflation and deflation with the cardiac cycle, thereby supporting coronary perfusion and improving myocardial oxygenation in patients with stable cardiovascular conditions. This non-invasive therapy is intended for use in clinical settings where cardiovascular function requires temporary or adjunctive mechanical assistance.

The device is supplied as a reusable system comprising sequential compression cuffs, a control unit, and associated tubing. It operates in a controlled clinical environment and requires proper training for operation and maintenance. The Model SECP-S is regulated under FDA 510(k) clearance (K022078) and falls under the product code DRN, adhering to regulatory standards for external counter-pulsation devices. No specific sterility or single-use designation is indicated in the available data.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Sola SECP-S counter-pulsation device used for?

    The Sola SECP-S is designed to augment peripheral blood flow by synchronizing cuff inflation and deflation with the cardiac cycle. This non-invasive therapy supports coronary perfusion and improves myocardial oxygenation in patients with stable cardiovascular conditions, providing temporary or adjunctive mechanical assistance in clinical settings.

  • Is the Sola SECP-S device single-use or reusable?

    The Sola SECP-S is supplied as a reusable system, including sequential compression cuffs, a control unit, and associated tubing. It is intended for use in controlled clinical environments where proper training for operation and maintenance is required.

  • How is the Sola SECP-S device regulated?

    The Sola SECP-S is regulated under FDA 510(k) clearance with the reference number K022078. It falls under the product code DRN and is classified as a Class II medical device, adhering to regulatory standards for external counter-pulsation devices.

  • Does the Sola SECP-S device require sterility?

    The available data does not specify a sterility designation for the Sola SECP-S device. Since it is a reusable system, proper cleaning and maintenance protocols must be followed to ensure safe and effective use in clinical settings.

  • What components are included in the Sola SECP-S supply?

    The Sola SECP-S is supplied as a reusable system comprising sequential compression cuffs, a control unit, and associated tubing. These components work together to deliver synchronized cuff inflation and deflation to support cardiovascular function.