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

DPO — Predicate Candidate Screening

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

35 daysmedian FDA review time

75 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K914833	IMMULITE DIGOXIN	Cirrus Diagnostics, Inc.	1991-11-22	28
K905719	ECLIPSE ICA DIGOXIN	Biotope, Inc.	1991-01-17	27
K864449	DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT	Canadian Bioclinical, Ltd.	1987-02-02	82
K833842	RIA COAT DIGOXIN	Immuno Assay Corp.	1984-01-17	75
K832163	SOPHEIA DIGOXIN EIA KIT	Diagnostic Products Corp.	1983-08-12	38
K830962	IMMUCHEM COVALENT-COAT RIA KIT	Immuchem Corp.	1983-05-04	37
K811932	COAT-A-COUNT DIGOXIN RIA	Diagnostic Products Corp.	1981-07-23	17
K811776	KALLESTAD QUANTICOAT 125 DIGOXIN	Kallestad Laboratories, Inc.	1981-07-10	17
K800205	RIA PHASE DIGOXIN	Boehringer Mannheim Corp.	1980-03-19	49
K791325	AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM	Micromedic Systems	1979-08-16	35
K791355	VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT	Ventrex Laboratories, Inc.	1979-08-10	20
K771638	IGOXIN SOLID PHASE RIA	Bd Becton Dickinson Vacutainer Systems Preanalytic	1977-10-07	42
K770365	RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO	Travenol Laboratories, S.A.	1977-02-24	1
K770069	DIGOXIN CLASP TM RIA KIT	E. R. Squibb & Sons, Inc.	1977-01-18	5

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