510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984564Substantially Equivalent

Ethyl Chloride Dispenser

Dukal Corp., New Port Riche FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984564 is the FDA 510(k) clearance record for ETHYL CHLORIDE DISPENSER, cleared for Dukal Corp. on under FDA product code MLY (Vapocoolant Device). FDA records list 2 510(k) clearances for Dukal Corp., from to . As of , FDA records show no recalls naming K984564.

Clearance record

Decision date
Received
(344 days to decision)
Product code
MLY Vapocoolant Device
Device class
Unclassified
Review panel
Unknown
Applicant
Dukal Corp. 3234 Ella Ln., New Port Riche FL
510(k) summary
Summary
Third party review
No

Clearances, product code MLY

Trailing 12 months
2 clearances under product code MLY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MLY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260