510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854126Substantially Equivalent

Craigwell Master Hearing Aid Mha

Craigwell Electronics, Ltd., Wiltshire Sn2 4bj, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854126 is the FDA 510(k) clearance record for CRAIGWELL MASTER HEARING AID MHA, a class II device, cleared for Craigwell Electronics, Ltd. on under FDA product code KHL (Hearing Aid, Master). FDA records list 3 510(k) clearances for Craigwell Electronics, Ltd., from to . As of , FDA records show no recalls naming K854126.

Clearance record

Decision date
Received
(99 days to decision)
Product code
KHL Hearing Aid, Master
Regulation
21 CFR 874.3330
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Craigwell Electronics, Ltd. Meadow Vale House, Wiltshire Sn2 4bj, GB
Third party review
No

Clearances, product code KHL

Trailing 12 months

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

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