510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K884046Substantially Equivalent

Audioscan(tm) Real Ear Measurement System Rm500

Etymonic Design, Inc., Dorchester, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884046 is the FDA 510(k) clearance record for AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500, a class II device, cleared for Etymonic Design, Inc. on under FDA product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems). FDA records list 2 510(k) clearances for Etymonic Design, Inc., from to . As of , FDA records show no recalls naming K884046.

Clearance record

Decision date
Received
(140 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
Etymonic Design, Inc. 41 Byron Ave., Dorchester, 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