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
K974658Substantially Equivalent

Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver, Infrared Headset Receiver-Stereo, It

Phonic Ear, Inc., Petaluma CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974658 is the FDA 510(k) clearance record for INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT, a class II device, cleared for Phonic Ear, Inc. on under FDA product code EPF (Hearing Aid, Group And Auditory Trainer). FDA records list 31 510(k) clearances for Phonic Ear, Inc., from to . As of , FDA records show no recalls naming K974658.

Clearance record

Decision date
Received
(72 days to decision)
Product code
EPF Hearing Aid, Group And Auditory Trainer
Regulation
21 CFR 874.3320
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Phonic Ear, Inc. 3880 Cypress Dr., Petaluma CA
510(k) summary
Summary
Third party review
No

Clearances, product code EPF

Trailing 12 months

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

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