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

CEX — Predicate Candidate Screening

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

55 daysmedian FDA review time

169 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days
K872891	LACTATE DEHYDROGENASE ISOENZYME 1	Data Medical Associates, Inc.	1987-09-16	55
K851521	LD-1(IMMUNO) SEPARATION SET	Seragen Diagnostics, Inc.	1985-05-10	25
K842018	ISO-SEP SYSTEM	Berwick Medical Products, Inc.	1984-09-28	133
K821983	TITAN GEL LDH ISOENZYME KIT	Helena Laboratories	1982-12-22	169
K821879	ULTRACHEM T.P.	Harleco Diagnostics	1982-07-14	19
K800129	CENTRIFICHEM CREATININE	Union Carbide Corp.	1980-02-13	26
K772356	LDH ISOENZYME COLUMN REAGENT SET	Worthington Biochemical Corp.	1978-01-24	28
K771894	LDH ISOENZYME CONTROL	Bio-Reagents & Diagnostics, Inc.	1977-12-22	77

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