510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863890Substantially Equivalent

Mamm-Aire

Ar Custom Medical Products, Ltd., Deer Park NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863890 is the FDA 510(k) clearance record for MAMM-AIRE, a class I device, cleared for Ar Custom Medical Products, Ltd. on under FDA product code KXH (Cradle, Patient, Radiologic). FDA records list one 510(k) clearance for Ar Custom Medical Products, Ltd. As of , FDA records show no recalls naming K863890.

Clearance record

Decision date
Received
(8 days to decision)
Product code
KXH Cradle, Patient, Radiologic
Regulation
21 CFR 892.1830
Device class
Class I
Review panel
Radiology
Applicant
Ar Custom Medical Products, Ltd. 19a W. Industry Ct., Deer Park NY
Third party review
No

Clearances, product code KXH

Trailing 12 months

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

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