510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801946Substantially Equivalent

CPR Helper

Cardia Concepts Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801946 is the FDA 510(k) clearance record for CPR HELPER, a class II device, cleared for Cardia Concepts Corp. on under FDA product code DRM (Compressor, Cardiac, External). FDA records list 3 510(k) clearances for Cardia Concepts Corp. As of , FDA records show no recalls naming K801946.

Clearance record

Decision date
Received
(97 days to decision)
Product code
DRM Compressor, Cardiac, External
Regulation
21 CFR 870.5200
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardia Concepts Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DRM

Trailing 12 months

FDA records hold no clearances under product code DRM in the trailing twelve months.

FDA records show no clearances under product code DRM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260