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
K863353Substantially Equivalent

Middle Ear Analyzer (Impedance Audiometer)

Grason-Stadler, Inc., Littleton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863353 is the FDA 510(k) clearance record for MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER), a class II device, cleared for Grason-Stadler, Inc. on under FDA product code ETY (Tester, Auditory Impedance). FDA records list 17 510(k) clearances for Grason-Stadler, Inc., from to . As of , FDA records show no recalls naming K863353.

Clearance record

Decision date
Received
(66 days to decision)
Product code
ETY Tester, Auditory Impedance
Regulation
21 CFR 874.1090
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Grason-Stadler, Inc. 537 Great Rd., P.O. Box 1400, Littleton MA
Third party review
No

Clearances, product code ETY

Trailing 12 months

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

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