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

Amplifon S.P.A. — Predicate Candidate Screening

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

88 daysmedian FDA review time

308 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K992370	AMPLAID A724 AND A728	Amplifon S.P.A.	1999-09-20	67
K983915	AMPLAID A315 AND A319	Amplifon S.P.A.	1999-01-29	86
K983712	AMPLAID A311 SERIES	Amplifon S.P.A.	1999-01-12	83
K971740	AMPLAID MK12	Amplifon S.P.A.	1998-03-16	308
K974235	AMPLAID AM50	Amplifon S.P.A.	1998-02-10	90
K972959	AMPLAID MK22	Amplifon S.P.A.	1998-02-06	179
K972862	AMPLAID 171S	Amplifon S.P.A.	1997-10-31	88
K971747	AMPLAID 460	Amplifon S.P.A.	1997-08-05	85

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