Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

EPF — Predicate Candidate Screening

32 FDA 510(k) clearances under this product code; the 50 most recent screened below.

72 daysmedian FDA review time

104 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days
K133352	HYPERSOUND AUDIO SYSTEM (HSS)	Hypersound Health, Inc.	2014-02-12	104
K982683	TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION	Telex Communications, Inc.	1998-10-06	67
K974658	INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRA	Phonic Ear, Inc.	1998-02-25	72
K974287	FM RECEIVER - AUDITORY TRAINER	Phonic Ear, Inc.	1998-02-10	88
K970687	WILLIAMS SOUND, PERSONAL FM, HEARING HELPER	Williams Sound, LLC	1997-05-02	67
K970665	WILLIAMS SOUND, PERSONAL FM, HEARING HELPER	Williams Sound, LLC	1997-05-02	70
K960567	HF MEGA EAR	Maxi-Aids, Inc.	1996-10-16	250
K950730	GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)	Phonic Ear, Inc.	1995-06-30	134
K941768	PHONAK MICROVOX RESONAL FM SYSTEM	Phonak, Inc.	1994-06-24	74
K940313	PHONIC EAR	Phonic Ear, Inc.	1994-03-22	57
K923234	PE 400IR, PE 400T, PE 400E	Phonic Ear, Inc.	1992-09-29	90
K922720	GROUP AUDITORY TRAINING SYSTEM	Phonic Ear, Inc.	1992-08-24	80
K922570	RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1	Resound Corp.	1992-08-06	66
K915383	TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER	Telex Communications, Inc.	1992-01-17	49
K915384	TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER	Telex Communications, Inc.	1992-01-17	49
K915397	TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER	Telex Communications, Inc.	1992-01-17	49
K915398	TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER	Telex Communications, Inc.	1992-01-17	49
K913495	TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC	Telex Communications, Inc.	1991-11-01	87
K913494	TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC	Telex Communications, Inc.	1991-11-01	87
K912356	GROUP AUDITORY TRAINER,FM RECEIVER	Phonic Ear, Inc.	1991-08-15	79
K893431	AUDITORY TRAINER PE150R FM RECEIVER	Phonic Ear, Inc.	1989-08-21	111
K882409	PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER	Phonic Ear, Inc.	1988-07-05	25
K881099	PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER	Phonic Ear, Inc.	1988-06-07	84
K862773	PHONIC EAR, MODEL PE475R	Phonic Ear, Inc.	1986-10-09	79
K832190	METAVOX MV-1000 AUDITORY TRAINER	Metavox, Inc.	1983-09-12	66
K832080	PHONIC EAR PE 467R-PE 461T	Phonic Ear, Inc.	1983-08-01	34
K821691	STIMRITE	Biotone International, Inc.	1982-08-25	78
K821511	POWERED MUSCLE STIMULATOR	High Country Ent.	1982-08-16	88
K810031	STEREO AUDITORY TRAINER (MODEL PM228)	Hc Electronics	1981-03-04	57
K780936	PHONIC EAR	Hc Electronics	1978-06-22	14
K771671	AUDITORY TRAINER	Accutone, Inc.	1977-09-12	11
K771357	GROUP AUDITORY TRAINER HC 431R	Hc Electronics	1977-07-29	7

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda