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

LJY — Predicate Candidate Screening

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

168 daysmedian FDA review time

737 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K991274	MUMPS IGG ELISA TEST SYSTEM	Columbia Bioscience, Inc.	1999-09-03	143	1
K980059	SERAQUEST MUMPS IGG	Quest Intl., Inc.	1998-04-23	106	0
K971857	MUMPS IGG ELISA TESTY	Gull Laboratories, Inc.	1997-11-04	168	0
K961204	MUMPS IGG TEST	Zeus Scientific, Inc.	1996-07-18	113	1
K925209	MUMPS STAT	Biowhittaker Molecular Applications, Inc.	1994-10-14	737	0
K923903	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA	Biomerieux Vitek, Inc.	1993-08-09	370	0
K897006	PHARMACIA MUMPS IGG ELISA	Pharmacia Eni Diagnostics, Inc.	1990-07-26	220	0
K830045	MUMPSELISA TEST KIT	M.A. Bioproducts	1983-05-13	123	0

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