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

Qualitone — Predicate Candidate Screening

39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

33 daysmedian FDA review time

96 days90th percentile

39clearances measured

K-number	Device	Applicant	Decided	Review days
K961827	IN-THE-EAR	Qualitone	1996-07-03	51
K955466	DYNAMEQ-II OPTION	Qualitone	1996-02-13	75
K955359	CYBER III OPTION UM, UC312, UC10, UCIC	Qualitone	1995-12-19	27
K953884	PROPHET	Qualitone	1995-10-27	71
K935348	ODYSSEY CLINICAL AUDIOMETER	Qualitone	1994-02-09	96
K935289	PRO FIT-CYBER II OPTION	Qualitone	1993-12-22	49
K923006	AS-90	Qualitone	1993-09-18	453
K923007	AT-2	Qualitone	1993-02-26	249
K923986	CYBERNETIC OPTION (CYBER I)	Qualitone	1992-09-10	34
K923013	ACOUSTIC APPRAISE CD-3	Qualitone	1992-08-14	53
K914017	UC312, ULTRA MINIATURE ITC HEARING AID	Qualitone	1991-09-23	14
K913781	QUALITONE 48PP-AGC-I, BEHIND THE EAR HEARING AID	Qualitone	1991-09-18	34
K913771	ELEGANCE - KED, BEHIND THE EAR HEARING AID	Qualitone	1991-09-18	27
K913592	QUALITONE 46PP-AGC-I	Qualitone	1991-09-18	37
K912153	QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR	Qualitone	1991-06-17	33
K912154	QUALITONE MODEL 48 C-WR-BEHIND THE EAR	Qualitone	1991-06-17	33
K911497	CUSTOM PERSONAL EAR - CPE	Qualitone	1991-04-19	18
K911504	ULTRA & ULTRA LITE II, MODIFICATION	Qualitone	1991-04-19	16
K911498	ADJUSTRETTE - DAO, MODIFICATION	Qualitone	1991-04-19	21
K911499	ELEGANCE - DEO, MODIFICATION	Qualitone	1991-04-19	21
K904731	QUALITONE ITE GENESIS	Qualitone	1990-12-17	61
K904730	QUALITONE ULTRA CANAL GENESIS	Qualitone	1990-12-07	51
K904544	ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID	Qualitone	1990-10-31	27
K892338	BEHIND-THE-EAR HEARING AID MODEL 48 AGCI	Qualitone	1989-08-03	120
K892336	BEHIND-THE-EAR HEARING AID MODEL 48 PP PC	Qualitone	1989-05-19	44
K892337	BEHIND-THE-EAR HEARING AID MODEL 46 PP PC	Qualitone	1989-05-10	35
K851970	QUALITONE STOCK CANAL AID	Qualitone	1985-06-04	28
K843789	ULTRA & ULTRA MINATURE	Qualitone	1984-12-13	77
K840165	CANAL AID	Qualitone	1984-04-03	78
K812578	ELEGANCE	Qualitone	1981-10-02	23
K810577	POWER SONIC	Qualitone	1981-03-31	28
K790093	MODULE PERSONAL EAR (SUPER)	Qualitone	1979-01-26	10
K790094	MODULE PERSONAL EAR (COMPRESSION)	Qualitone	1979-01-26	10
K790095	MODULE PERSONAL EAR (DELUXE)	Qualitone	1979-01-26	10
K780241	COMPRESSION MULTISONIC	Qualitone	1978-02-17	4
K771069	MULTISONIC (SUPER) CODE TSM	Qualitone	1977-06-24	11
K771029	MULTISONIC (DELUXE) CODE TDM	Qualitone	1977-06-22	13
K770251	SUPER X ADJUSTRETTE	Qualitone	1977-02-28	19
K760887	COMPRESSION ADJUSTRETTE	Qualitone	1976-11-03	12

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