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

MJA · Predicate Candidate Screening

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

147 daysmedian FDA review time

719 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K052323	VERSATREK MYCO PZA KIT	Trek Diagnostic Systems, Inc.	2006-01-19	147	0
K021582	BACTEC MGIT 960 PZA KIT	Becton, Dickinson & CO	2002-07-13	60	2
K014123	BACTEC MGIT 960 SIRE KITS	Becton, Dickinson & CO	2002-04-19	123	0
K003062	BACTEC MGIT 960 SIR KITS	Bd Becton Dickinson Vacutainer Systems Preanalytic	2001-06-06	247	0
K972772	ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING	Trek Diagnostic Systems, Inc.	1999-07-13	719	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