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

Phonak, Inc. — Predicate Candidate Screening

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

36 daysmedian FDA review time

91 days90th percentile

37clearances measured

K-number	Device	Applicant	Decided	Review days
K972106	PHONAK NOVO FORTE E3	Phonak, Inc.	1997-08-15	71
K972105	PHONAK EPICA	Phonak, Inc.	1997-08-01	57
K972097	PHONAK MICROZOOM P 2	Phonak, Inc.	1997-07-30	56
K964035	PHONAK MICROLINK, PERSONAL FM RECEIVER	Phonak, Inc.	1996-12-04	57
K961653	PHONAK SONA P2	Phonak, Inc.	1996-05-29	29
K961622	PHONAK PICONET2 P2 AZ	Phonak, Inc.	1996-05-17	21
K953921	PHONAK 9900 CIC	Phonak, Inc.	1995-09-18	28
K945439	PHONAK PICONET 232X-AZ HEARING INSTRUMENT	Phonak, Inc.	1995-08-23	299
K950758	DYNA 231X	Phonak, Inc.	1995-03-21	32
K946294	PHONAK SONO-FORTE 332X-AZ	Phonak, Inc.	1995-01-26	30
K941768	PHONAK MICROVOX RESONAL FM SYSTEM	Phonak, Inc.	1994-06-24	74
K941734	PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS	Phonak, Inc.	1994-05-13	36
K935791	PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT	Phonak, Inc.	1994-01-26	50
K932735	PHONAK PICO-FORTE SC-D-2	Phonak, Inc.	1993-07-27	50
K932734	PHONAK PICO-FORTE SC-2	Phonak, Inc.	1993-07-27	50
K932175	PHONAK LEXA 231X ITE SERIES HEARING SINSTRUMENT	Phonak, Inc.	1993-07-08	64
K930145	PHONAK PICONET 231-X	Phonak, Inc.	1993-02-01	20
K924911	PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT	Phonak, Inc.	1992-11-04	36
K924913	PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR	Phonak, Inc.	1992-11-04	36
K924914	PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT	Phonak, Inc.	1992-11-04	36
K924912	PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT	Phonak, Inc.	1992-11-03	35
K923743	BTE WITH ACCESSORY ATTACHED	Phonak, Inc.	1992-09-28	63
K915461	PHONAK 9000-AF ITE HEARING INSTRUMENT SERIES	Phonak, Inc.	1991-12-30	26
K913503	PHONAK PICO-FORTE PP-C-P BTE HEARING INSTRUMENT	Phonak, Inc.	1991-09-06	30
K913502	PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT	Phonak, Inc.	1991-09-06	30
K912570	PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT	Phonak, Inc.	1991-06-26	15
K912571	PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT	Phonak, Inc.	1991-06-26	15
K911211	PHONAK 9100 SC-AF ITE HEARING INSTRUMENT	Phonak, Inc.	1991-04-17	29
K911210	PHONAK 9800 SC-AF ITE HEARING INSTRUMENT	Phonak, Inc.	1991-04-17	29
K911209	PHONAK 9300 SC-AF ITE HEARING INSTRUMENT	Phonak, Inc.	1991-04-15	27
K910028	POST AURICULAR HEARING AID MODEL PICO SC-H	Phonak, Inc.	1991-03-08	63
K910018	POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC	Phonak, Inc.	1991-02-28	55
K910012	PHONAK MODEL PICO C-S-H-T, BTE HEARING AID	Phonak, Inc.	1991-02-28	57
K900829	BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC	Phonak, Inc.	1990-05-23	91
K900830	BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4	Phonak, Inc.	1990-05-23	91
K900675	PHONAK ITE 8000, 7000, 6000 ITE HEARING AID	Phonak, Inc.	1990-05-23	100
K900831	BTE PICO SCD, PICO SC	Phonak, Inc.	1990-05-23	91

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