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

HYB · Predicate Candidate Screening

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

23 daysmedian FDA review time

49 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K893663	INSTANT EOSIN-AQUEOUS	Shandon, Inc.	1989-06-13	29
K880596	EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE	Sigma Chemical Co.	1988-03-31	49
K880240	INSTANT EOSIN-ALCOHOLIC	Shandon, Inc.	1988-03-03	43
K843426	EOSIN Y 1% ALCOHOLIC	Accra Laboratories, Inc.	1984-09-27	23
K822982	MIDAS 100 HEMACOLOR STAIN #66030	Emd Chemicals, Inc.	1982-10-27	19
K821574	EOSIN Y SOLUTIN, AGUEOUS	Sigma Chemical Co.	1982-06-10	14
K821573	EOSIN Y SOLUTION ALCHOLIC	Sigma Chemical Co.	1982-06-09	13
K811797	EOSIN-Y	Richard-Allan Medical Ind., Inc.	1981-07-28	34
K811826	EOSIN Y	Surgipath	1981-07-10	11
K800942	VOLU-SOL EOSIN Y STAIN	Volu Sol Medical Industries	1980-05-08	16

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