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

MJJ — Predicate Candidate Screening

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

148 daysmedian FDA review time

484 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K182442	MiniGuard Arterial Safety Valve	Quest Medical, Inc.	2018-11-06	60	0
K142500	One Way Soft Valve	Terumo Cardiovascular Systems Corporation	2015-01-29	146	0
K001245	3T L. V. CONTROL VALVE	3t Medical Systems, LLC	2001-08-15	484	36
K992785	IBC FLOGUARD, MODEL 6050	International Biophysics Corp.	2000-01-14	148	0
K982406	COBE VACUUM RELIEF CHECK VALVE	Cobe Cardiovascular, Inc.	1998-10-07	89	0
K960937	SUCTION SAFETY DEVICE	R D Intl.	1996-06-05	89	0
K922781	FLOW CONROL VALVE	American Omni Medical, Inc.	1993-03-08	272	0
K922356	FLOW CONTROL VALVE, CAT. NO. ACV-38	American Omni Medical, Inc.	1993-02-12	269	0
K921500	CENTRI-SAFE(TM) VALVE	Cardio Systems, Inc.	1992-09-15	168	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