510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K022078Substantially Equivalent

Sola, Counter-Pulsation, Model Secp-S

Sola Medical Devices, LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022078 is the FDA 510(k) clearance record for SOLA, COUNTER-PULSATION, MODEL SECP-S, a class II device, cleared for Sola Medical Devices, LLC on under FDA product code DRN (Device, Counter-Pulsating, External). FDA records list one 510(k) clearance for Sola Medical Devices, LLC. As of , FDA records show no recalls naming K022078.

Clearance record

Decision date
Received
(198 days to decision)
Product code
DRN Device, Counter-Pulsating, External
Regulation
21 CFR 870.5225
Device class
Class II
Review panel
Cardiovascular
Applicant
Sola Medical Devices, LLC 3722 Ave. Sausalito, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRN

Trailing 12 months
1 clearance under product code DRN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260