Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

DOF · Predicate Candidate Screening

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

260 daysmedian FDA review time

288 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K142705	LeadCare Plus Blood Lead Testing System	Magellan Diagnostics	2015-07-07	288	3
K123563	LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM	Magellan Diagnostics	2013-08-20	274	2
K052549	LEADCARE II BLOOD LEAD TESTING SYSTEM	Esa Biosciences, Inc.	2005-10-06	20	10
K971640	LEADCARE BLOOD LEAD TESTING SYSTEM	Esa, Inc.	1997-09-09	130	2
K936060	ATOMSPEC GF BLOOD LEAD WORKSTATION	Thermo Jarrell Ash Corp.Div.Thermo Inst.	1994-09-06	260	0
K843839	STAT/PB REAGENT	Tri-Tech, Inc.	1985-01-03	94	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