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

MJX — Predicate Candidate Screening

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

59 daysmedian FDA review time

194 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K101434	AUDIT MICROCV PROCALCITONIN LINEARITY	Aalto Scientific, Ltd.	2010-07-22	62
K030067	VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS	Ortho-Clinical Diagnostics	2003-01-17	10
K974262	SYSCOS IDC - G, IDC, BSC, IDC - G	Scantibodies Laboratory, Inc.	1997-12-24	41
K972986	ACCURUN 140 RUBELLA IGG POSITIVE CONTROL	Boston Biomedica, Inc.	1997-10-08	58
K970100	TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK S	Simplicity Diagnostics, Inc.	1997-03-10	59
K934137	OPUS(R) SEROLOGY CONTROLS, MODIFICATION	Pb Diagnostic Systems, Inc.	1994-03-07	194
K925703	OPUS SEROLOGY CONTROLS	Pb Diagnostics, Inc.	1993-04-08	147

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