510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801905Substantially Equivalent

Fonix Type 5100 Hearing Aid Analyzer

Frye Electronics, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801905 is the FDA 510(k) clearance record for FONIX TYPE 5100 HEARING AID ANALYZER, a class II device, cleared for Frye Electronics, Inc. on under FDA product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems). FDA records list 13 510(k) clearances for Frye Electronics, Inc., from to . As of , FDA records show no recalls naming K801905.

Clearance record

Decision date
Received
(16 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
Frye Electronics, Inc. 4221 Richmond Rd., NW, Walker MI
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