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

KHH · Predicate Candidate Screening

7 FDA 510(k) clearances under this product code; the 50 most recent screened below.

127 daysmedian FDA review time

201 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K950785	HORTMANN AIRMATIC AIR CALORIC STIMULATOR	Jedmed Instrument Co.	1995-06-28	127
K946108	EAR-A-GATOR	Life-Tech Intl., Inc.	1995-06-13	181
K941325	WATER IRRIGATOR, W1 200	Strong Medical, Inc.	1994-08-09	144
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
K822179	FRENZEL EYEGLASSES & RELATED ITEMS	Kelleher Corp.	1982-09-21	60

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