510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K922093Substantially Equivalent

Haskel CPR

Haskel, Inc., Burbank CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922093 is the FDA 510(k) clearance record for HASKEL CPR, a class II device, cleared for Haskel, Inc. on under FDA product code DRM (Compressor, Cardiac, External). FDA records list one 510(k) clearance for Haskel, Inc. As of , FDA records show no recalls naming K922093.

Clearance record

Decision date
Received
(678 days to decision)
Product code
DRM Compressor, Cardiac, External
Regulation
21 CFR 870.5200
Device class
Class II
Review panel
Cardiovascular
Applicant
Haskel, Inc. 100 E. Graham Pl., Burbank CA
510(k) summary
Statement
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