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

Ics Medical Corp. · Predicate Candidate Screening

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

90 daysmedian FDA review time

908 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K011181	ICS MEDICAL CHARTR OAE WITH TYMP	Ics Medical Corp.	2001-06-25	68
K002985	ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS	Ics Medical Corp.	2000-12-13	79
K991497	ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM	Ics Medical Corp.	1999-07-28	90
K972631	ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER	Ics Medical Corp.	1997-09-22	70
K960097	CHARTR EP	Ics Medical Corp.	1997-02-21	407
K931609	CHARTR ENG SYSTEM	Ics Medical Corp.	1995-09-26	908
K931608	NCA-200	Ics Medical Corp.	1993-06-22	82
K925237	AUTOMATIC CALORIC IRRIGATION SYSTEM	Ics Medical Corp.	1993-05-05	201
K881630	AUTOMATIC CALORIC IRRIGATION SYSTEM	Ics Medical Corp.	1988-06-21	68
K872093	RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING	Ics Medical Corp.	1987-09-16	107

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