510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822240Substantially Equivalent

Ethylene Oxide Steriliz. Parametric Rel.

American Mcgaw, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822240 is the FDA 510(k) clearance record for ETHYLENE OXIDE STERILIZ. PARAMETRIC REL., a class II device, cleared for American Mcgaw on under FDA product code KFX (Assembly, Thigh/Knee/Shank/Ankle/Foot, External). FDA records list 13 510(k) clearances for American Mcgaw, from to . As of , FDA records show no recalls naming K822240.

Clearance record

Decision date
Received
(156 days to decision)
Product code
KFX Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Regulation
21 CFR 890.3500
Device class
Class II
Review panel
Physical Medicine
Applicant
American Mcgaw P.O. Box 1187, Santa Ana CA
Third party review
No

Clearances, product code KFX

Trailing 12 months

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

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