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

LED — Predicate Candidate Screening

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

23 daysmedian FDA review time

69 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K051409	SLIVASURE	Scandinavian Formulas, Inc.	2005-08-08	69
K023046	SST SALIVA SUPPORTING TABLETS	Sinclair Pharmaceuticals, Ltd.	2002-12-02	81
K860795	SPOTTEST CALCOFLUOR WHITE REAGENT	Difco Laboratories, Inc.	1986-03-12	8
K860319	MEGACOLOR	Cytocolor, Inc.	1986-02-20	23
K860317	NEUTROCOLOR	Cytocolor, Inc.	1986-02-20	23
K860321	LYSOCOLOR	Cytocolor, Inc.	1986-02-20	23
K860320	GRANULOCOLOR	Cytocolor, Inc.	1986-02-20	23
K860316	PANOPTIKON	Cytocolor, Inc.	1986-02-20	23
K854176	POLYCHROME IV STAIN	Devetec, Inc.	1985-10-31	16
K851481	SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR	Difco Laboratories, Inc.	1985-04-29	14
K842930	GOMORI'S TRICHROME STAIN	E K Ind., Inc.	1984-09-11	48
K842727	SUPERMOUNT	E K Ind., Inc.	1984-08-03	21
K840087	PRESERV GOMORI TRICHROME STAIN 125/500	Preventive Diagnostics Corp.	1984-02-10	31
K833167	TRICHROME STAIN LG SOLUTION	Sigma Chemical Co.	1983-10-31	45
K833388	IRON STAIN PROCEDURE HT20	Sigma Chemical Co.	1983-10-31	33
K812192	LACTO-PHENOL ANILINE BLUE MOUNTING FLUID	American Scientific Products	1981-08-31	28

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