510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900419Substantially Equivalent

Cryotron-Ul30

Henley Intl., Sugar Land TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900419 is the FDA 510(k) clearance record for CRYOTRON-UL30, a class I device, cleared for Henley Intl. on under FDA product code IMF (Unit, Chilling). FDA records list 44 510(k) clearances for Henley Intl., from to . As of , FDA records show no recalls naming K900419.

Clearance record

Decision date
Received
(28 days to decision)
Product code
IMF Unit, Chilling
Regulation
21 CFR 890.5940
Device class
Class I
Review panel
Physical Medicine
Applicant
Henley Intl. 104 Industrial Blvd.,, Sugar Land TX
Third party review
No

Clearances, product code IMF

Trailing 12 months

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

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