510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903946Substantially Equivalent

Cool Cast(r)

Hawthorne Products, Inc., Dunkirk IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903946 is the FDA 510(k) clearance record for COOL CAST(R), a class I device, cleared for Hawthorne Products, Inc. on under FDA product code LGF (Component, Cast). FDA records list one 510(k) clearance for Hawthorne Products, Inc. As of , FDA records show no recalls naming K903946.

Clearance record

Decision date
Received
(126 days to decision)
Product code
LGF Component, Cast
Regulation
21 CFR 888.5940
Device class
Class I
Review panel
Orthopedic
Applicant
Hawthorne Products, Inc. Box 66, R.D. #2, Dunkirk IN
Third party review
No

Clearances, product code LGF

Trailing 12 months

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

FDA records show no clearances under product code LGF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LGF, 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