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

DON — Predicate Candidate Screening

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

33 daysmedian FDA review time

74 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days
K902861	CIBA CORNING ACS DIGOXIN IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1990-09-10	74
K881679	CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY	Ciba Corning Diagnostics Corp.	1988-07-08	80
K840461	MAGIC 125I DIGOXIN RADIOIMMUNOASSAY	Corning Medical & Scientific	1984-03-23	50
K830533	PHASE II DIGOXIN RADIOIMMUNOASSAY KIT	Medical & Scientific Designs, Inc.	1983-04-05	46
K822053	ZETAPHASE-DIG	Biological & Diagnostic Products	1982-07-27	14
K821000	ENZYMUNE-TEST DIGOXIN	Icl Scientific	1982-04-26	18
K810296	DIGOXIN RIA ASSAY	Ria Diagnostics	1981-02-19	15
K803075	DIGOXIN RIABEAD DIAGNOSTIC KIT	Abbott Laboratories	1980-12-22	17
K791549	TECHNICON STAR SYSTEM	Technicon Instruments Corp.	1979-09-27	45
K781660	RIA, DIGOXIN	E. R. Squibb & Sons, Inc.	1978-10-24	26
K780475	DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT	Burroughs Wellcome Co.	1978-04-24	31
K780207	LIQUISOL DIGOXIN RIA TEST KIT	Damon Corp.	1978-02-23	16
K772422	QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA	Bio-Rad	1978-02-13	47
K772098	DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS	Bd Becton Dickinson Vacutainer Systems Preanalytic	1977-12-20	43
K771255	CEBTRIA DIGOXIN RIA	Union Carbide Corp.	1977-08-25	44
K770269	CAMMADISK DIGOXIN	Burroughs Wellcome Co.	1977-03-16	33
K760800	SPAC DIGOXIN KIT	Mallinckrodt Critical Care	1976-11-01	24

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