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

Gn Otometrics — Predicate Candidate Screening

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

105 daysmedian FDA review time

165 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K161707	Madsen Zodiac	Gn Otometrics	2016-09-01	72
K151504	ICS Impulse	Gn Otometrics	2015-11-16	165
K132957	MADSEN ACCUSCREEN TYPE 1077	Gn Otometrics	2014-02-27	160
K122550	ICS IMPULSE	Gn Otometrics	2013-02-01	164
K122028	AURICAL HIT	Gn Otometrics	2012-10-23	105
K122067	TYPE 1077 ACCUSCREEN	Gn Otometrics	2012-09-27	73
K092373	ICS CHARTR EP 200	Gn Otometrics	2009-09-03	29
K081234	GN OTOMETRICS INSERT EARPHONES	Gn Otometrics	2008-07-14	74

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