510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203661Substantially Equivalent

CRYO Arctic, CRYO Penguin

Cryoscience North America, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203661 is the FDA 510(k) clearance record for CRYO Arctic, CRYO Penguin, cleared for Cryoscience North America, Inc. on under FDA product code MLY (Vapocoolant Device). FDA records list one 510(k) clearance for Cryoscience North America, Inc. As of , FDA records show no recalls naming K203661.

Clearance record

Decision date
Received
(526 days to decision)
Product code
MLY Vapocoolant Device
Device class
Unclassified
Review panel
Unknown
Applicant
Cryoscience North America, Inc. 401 Louisuana St., 8th Floor, Houston TX
510(k) summary
Summary PDF
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