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

E K Ind., Inc. — Predicate Candidate Screening

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

44 daysmedian FDA review time

58 days90th percentile

50clearances measured

K-number	Device	Applicant	Decided	Review days
K842931	DRABKIN REAGENT	E K Ind., Inc.	1984-09-21	58
K842938	ACETIC ACID 1% V/V	E K Ind., Inc.	1984-09-14	51
K842937	ACETIC ACID 2% V/V	E K Ind., Inc.	1984-09-12	49
K842936	ACETIC ACID, 3% V/V	E K Ind., Inc.	1984-09-12	49
K842934	DECOLORIZING FLUIC, ACID-ALCOHOL 3%	E K Ind., Inc.	1984-09-12	49
K842935	ACETIC ACID, 5% V/V	E K Ind., Inc.	1984-09-12	49
K842731	FORMALIN-ACETO-ALCOHOL FIXATIVE	E K Ind., Inc.	1984-09-11	60
K842927	LIGHT GREEN SF 1%	E K Ind., Inc.	1984-09-11	48
K842735	PAP STAIN EA-65	E K Ind., Inc.	1984-09-11	60
K842916	SUDAN IV HERXHEIMER	E K Ind., Inc.	1984-09-11	48
K842739	PAP STAIN, EA-36	E K Ind., Inc.	1984-09-11	60
K842925	MUCI-CARMINE STAIN, MAYER'S FORMULA	E K Ind., Inc.	1984-09-11	48
K842933	CARBOL-FUCHSIN, ZIEHL-NEEDSEN	E K Ind., Inc.	1984-09-11	48
K842926	METHYLENE BLUE STAIN, LOEFFLER	E K Ind., Inc.	1984-09-11	48
K842923	PICRIC ACID 1% W/V	E K Ind., Inc.	1984-09-11	48
K842919	SCHIFF REAGENT FUCHSIN-SULFUROUS ACID	E K Ind., Inc.	1984-09-11	48
K842918	SCOTTS TAP WATER SUBSTITUTE	E K Ind., Inc.	1984-09-11	48
K842928	JENNER BLOOD STAIN	E K Ind., Inc.	1984-09-11	48
K842722	BUFFERED SALINE	E K Ind., Inc.	1984-09-11	60
K842930	GOMORI'S TRICHROME STAIN	E K Ind., Inc.	1984-09-11	48
K842921	REES & ECKER DILUTION FLUID	E K Ind., Inc.	1984-09-07	44
K842917	SCHIFF REAGENT, PAS STAIN	E K Ind., Inc.	1984-09-07	44
K842913	WRIGHT STAIN FIXATIVE	E K Ind., Inc.	1984-09-07	44
K842737	CARNOY'S SOLUTION	E K Ind., Inc.	1984-09-07	56
K842924	ORANGE G, 1%	E K Ind., Inc.	1984-09-07	44
K842929	HAYEM DILUTING FLUID	E K Ind., Inc.	1984-09-07	44
K842922	PICRIC ACID SATURATED SOLUTION	E K Ind., Inc.	1984-09-07	44
K842914	WRIGHT STAIN BUFFER	E K Ind., Inc.	1984-09-07	44
K842734	SAFRANIN STAIN	E K Ind., Inc.	1984-08-17	35
K842740	DELAFIELD HEMATOXYLIN STAIN	E K Ind., Inc.	1984-08-17	35
K842738	PAP STAIN EA-50	E K Ind., Inc.	1984-08-17	35
K842736	PAP STAIN, OG-6	E K Ind., Inc.	1984-08-17	35
K842742	GIEMSA STAIN	E K Ind., Inc.	1984-08-15	33
K842741	GILL HEMATOXYLIN STAIN	E K Ind., Inc.	1984-08-15	33
K842744	WRIGHT STAIN	E K Ind., Inc.	1984-08-12	30
K842743	NEW METHYLENE BLUE N	E K Ind., Inc.	1984-08-12	30
K842915	SULFOSALICYLIC ACID, 3% W/V	E K Ind., Inc.	1984-08-10	16
K842745	WRIGHT-GIEMSA QUICK STAIN	E K Ind., Inc.	1984-08-10	28
K842733	GRAM IODINE	E K Ind., Inc.	1984-08-10	28
K842723	SALINE, 1.3% W/O PRESERVATIVE	E K Ind., Inc.	1984-08-03	21
K842721	LIMONENE	E K Ind., Inc.	1984-08-03	21
K842726	DECALCIFIER SOLUTION	E K Ind., Inc.	1984-08-03	21
K842730	GENTIAN VIOLET	E K Ind., Inc.	1984-08-03	21
K842727	SUPERMOUNT	E K Ind., Inc.	1984-08-03	21
K842732	ZENKERS SOLUTION	E K Ind., Inc.	1984-08-03	21
K842725	SALINE, 0.85%W/PRESERVATIVE	E K Ind., Inc.	1984-08-03	21
K842724	SALINE 0.85% W/O PRESERVATIVE	E K Ind., Inc.	1984-08-03	21
K842728	BUF-FIX	E K Ind., Inc.	1984-08-03	21
K842729	DECOLORIZING FLUID	E K Ind., Inc.	1984-08-03	21
K842920	SAFRANIN, 1% W/V	E K Ind., Inc.	1984-07-25	0

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