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

Grason-Stadler, Inc. — Predicate Candidate Screening

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

80 daysmedian FDA review time

130 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K180287	GSI Corti	Grason-Stadler, Inc.	2018-05-11	99
K172403	GSI Novus	Grason-Stadler, Inc.	2017-10-20	72
K000097	GSI 2000 MIDDLE EAR ANALYZER	Grason-Stadler, Inc.	2000-04-12	90
K974237	GSI 70 AUDIOPATH SCREENER	Grason-Stadler, Inc.	1998-02-10	90
K970324	GSI SA60 DPOAE SYSTEM	Grason-Stadler, Inc.	1997-06-06	130
K953684	GSI 61 CLINICAL AUDIOMETER	Grason-Stadler, Inc.	1995-10-27	85
K951759	GSI 65 COMPUTERIZED AUDIOMETER	Grason-Stadler, Inc.	1995-07-06	80
K902540	GSI 17 SCREENING AUDIOMETER	Grason-Stadler, Inc.	1990-07-13	37
K890124	ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER	Grason-Stadler, Inc.	1989-07-14	184
K870030	THE SCREENER GSI 55 ABR SCREENER	Grason-Stadler, Inc.	1987-03-13	67
K863353	MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)	Grason-Stadler, Inc.	1986-11-03	66
K843618	AUDIOMETER	Grason-Stadler, Inc.	1984-12-03	80
K820715	MIDDLE EAR ANALYZER (IMPEDANCE AUDIO	Grason-Stadler, Inc.	1982-04-09	25
K810583	AUDIOMETER	Grason-Stadler, Inc.	1981-04-29	57
K790846	MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)	Grason-Stadler, Inc.	1979-05-17	13
K790609	AUDIOMETER	Grason-Stadler, Inc.	1979-04-10	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