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

DEG — Predicate Candidate Screening

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

79 daysmedian FDA review time

165 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K071712	LEUKO EZ VUE	Techlab Inc., Corporate Research Center	2007-12-04	165
K042071	IBD-SCAN	Techlab, Inc.	2004-10-20	79
K030704	IBD-QUIK CHEK	Techlab, Inc.	2003-04-21	46
K011396	IBD-CHEK	Techlab, Inc.	2001-06-18	42
K951101	LEUKO-TEST	Techlab, Inc.	1995-04-24	45
K934473	LACTOFERRIN MICROASSAY SYSTEM	Touch Scientific, Inc.	1993-12-03	80
K931901	LACTOCARD	Touch Scientific, Inc.	1993-07-06	78
K852737	LACTOPLATE	Mackeen Consultants, Ltd.	1985-10-25	120

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