510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854535Substantially Equivalent

Insertion Gain Optimizer Igo-1000

Madsen Electronics (Canada), Ltd., Oakville, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854535 is the FDA 510(k) clearance record for INSERTION GAIN OPTIMIZER IGO-1000, a class II device, cleared for Madsen Electronics (Canada) , Ltd. on under FDA product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems). FDA records list 17 510(k) clearances for Madsen Electronics (Canada) , Ltd., from to . As of , FDA records show no recalls naming K854535.

Clearance record

Decision date
Received
(99 days to decision)
Product code
ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Regulation
21 CFR 874.3310
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Madsen Electronics (Canada) , Ltd. 2370 Speers Rd., Oakville, Ontario, CA
Third party review
No

Clearances, product code ETW

Trailing 12 months

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

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