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

DJD · Predicate Candidate Screening

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

50 daysmedian FDA review time

57 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K973582	ACE PRIMIDONE REAGENT, AED CALIBRATORS	Schiapparelli Biosystems, Inc.	1997-11-12	51
K910527	EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE	Syva Co.	1991-03-14	35
K840939	EMIT QST PRIMIDONE ASSAY	Syva Co.	1984-04-24	50
K832798	MODIFICA-OF EMIT AED PRIMIDONE ASSAY	Syva Co.	1983-10-14	57
K820138	PRIMIDONE REAGENT TEST KIT	Beckman Instruments, Inc.	1982-01-28	10
K813597	TDX PRIMIDONE	Abbott Laboratories	1982-01-22	25
K802654	AMES TDA PRIMIDONE TEST	Miles Laboratories, Inc.	1980-11-12	19
K781957	ANALYTICAL TEST PACK, PRIMIDONE	E.I. Dupont DE Nemours & Co., Inc.	1979-01-10	50

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