Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

DPB — Predicate Candidate Screening

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

21 daysmedian FDA review time

125 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K853021	OPTIMATE DIGOXIN TEST	Miles Laboratories, Inc.	1985-08-07	20
K823014	DIGOXIN KIT	Pcl-Ria, Inc.	1982-11-01	19
K821811	125I DIGOXIN RADIOIMMUNOASSAY KIT	Cambridge Medical Technology	1982-07-02	14
K820274	DIGOXIN RADIOIMMUNOASSAY	American Diagnostic Corp.	1982-02-23	21
K792153	DIGOXIN RADIOIMMUNOASSAY SYSTEM	Radioimmunoassay, Inc.	1979-11-13	18
K790602	RIA, DIGNXIN-125-I	Endocrine-Metabolic Center	1979-07-30	125
K790540	RIA TEST KIT, CENTRIA DIGOXIN	Ventrex Laboratories, Inc.	1979-04-23	34
K772306	125I DIGOXIN TEST SET	Wien Laboratories, Inc.	1977-12-22	7
K771525	125 I DIGOXIN RIA KIT	Diagnostic Products Corp.	1977-10-14	67
K760883	DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY	Nuclear Medical Laboratories, Inc.	1976-11-19	29

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