510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854920Substantially Equivalent for Some Indications

Therapy Cassetts

Alpha Therapeutic Corp., Rouses Point NY / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K854920 is the FDA 510(k) clearance record for THERAPY CASSETTS, cleared for Alpha Therapeutic Corp. on under FDA product code MCU. FDA records list 8 510(k) clearances for Alpha Therapeutic Corp., from to . As of , FDA records show no recalls naming K854920.

Clearance record

Decision date
Received
(160 days to decision)
Product code
MCU
Review panel
Unknown
Applicant
Alpha Therapeutic Corp. P.O. Box 516, Rouses Point NY
Third party review
No

Clearances, product code MCU

Trailing 12 months

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

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