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

Oticon, Inc. — Predicate Candidate Screening

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

27 daysmedian FDA review time

50 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K973886	OTICON DIGISOUND COMPACT	Oticon, Inc.	1997-11-04	21
K973885	OTICON DIGISOUND ITE	Oticon, Inc.	1997-11-04	21
K964683	DIGIFOCUS ITE	Oticon, Inc.	1996-12-12	20
K961059	DIGIFOCUS COMPACT	Oticon, Inc.	1996-05-07	50
K960284	OTICON /PRIMOFOCUS (PF)	Oticon, Inc.	1996-03-07	48
K954794	OTICON	Oticon, Inc.	1995-11-13	26
K950381	OTICON/LOGIC	Oticon, Inc.	1995-02-27	27
K946045	OTICON	Oticon, Inc.	1995-01-30	49
K933307	MULTIFOCUS COMPACT BTE HEARING AID	Oticon, Inc.	1993-08-23	47

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