510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781491Substantially Equivalent

Pro-Mold, Custom Ear

Mcghan Medical Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781491 is the FDA 510(k) clearance record for PRO-MOLD, CUSTOM EAR, cleared for Mcghan Medical Corp. on under FDA product code EWD (Protector, Hearing (Insert)). FDA records list 14 510(k) clearances for Mcghan Medical Corp., from to . As of , FDA records show no recalls naming K781491.

Clearance record

Decision date
Received
(30 days to decision)
Product code
EWD Protector, Hearing (Insert)
Device class
Unclassified
Review panel
Unknown
Applicant
Mcghan Medical Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EWD

Trailing 12 months

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

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