Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

MGZ — Predicate Candidate Screening

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

163 daysmedian FDA review time

353 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260188	LimFlow Vector	LimFlow, Inc.	2026-03-18	55	0
K250105	Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome	Aveera Medical, Inc.	2025-07-03	169	0
K221902	LimFlow Vector	LimFlow, Inc.	2022-12-21	174	1
K190267	EZE SIT Valvulotome	Lemaitre Vascular	2019-10-30	264	0
K142660	Antegrade LeMills Valvulotome	LeMaitre Vascular, Inc.	2014-10-17	29	0
K140042	1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME	LeMaitre Vascular, Inc.	2014-04-10	92	0
K132047	LEMILLS VALVULOTOME	LeMaitre Vascular, Inc.	2013-11-05	126	0
K132190	EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALV	LeMaitre Vascular, Inc.	2013-08-05	21	0
K111884	OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME	LeMaitre Vascular, Inc.	2011-07-29	28	0
K080178	VALVULOTOME BY KOVEN	Koven Technology, Inc.	2008-07-28	186	0
K022823	VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-752	Geister Medizin Technik GmbH	2004-07-01	675	0
K001734	FOGARTY VALVULOTOME, MODEL 700091	Edwards Lifesciences, LLC	2001-03-26	292	0
K980723	2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)	Vascutech, Inc.	1999-02-12	353	0
K965137	FOGARTY VALVULOTOME MODEL 700091	Baxter Edwards	1997-06-04	163	0
K946352	LEMAITRE VALVULOTOME II	Vascutech, Inc.	1995-06-21	173	0
K925283	VALVULOTOME	Intramed Laboratories, Inc.	1994-02-10	478	0
K932009	THE SAMUELS RETROGRAD VALVULOTOME	Vascutech, Inc.	1993-09-21	151	0
K930011	URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS	Uresil Corp.	1993-05-26	142	0
K924171	LEMAITRE RETROGRADE VALVULOTOME	Vascutech, Inc.	1993-02-16	182	0
K924075	DISPOSABLE OPTICAL VALVULOTOME	Endovascular, Inc.	1993-02-08	180	0
K914385	OPTICAL VALVULOTOME	Intramed Laboratories, Inc.	1992-03-02	153	0
K911184	SCANLAN/TAHERI VALVULOTOME	Scanlan Intl., Inc.	1992-02-18	337	0
K914457	DISPOSABLE OPTICAL VALVULOTOME	Nobles-Lai Engineering, Inc.	1992-02-05	121	0
K911702	OLYMPUS RETRACTABLE VALVULOTOME	Olympus Corp.	1991-12-27	255	0
K912636	ANNULUS VALVULOTOME	Cardio Source	1991-10-18	126	0
K912635	ANNULUS DISPOSABLE VALVULOTOME	Cardio Source	1991-10-18	126	0
K911100	MEHIGAN-PILLING PHLEBETOME TM	Pilling Co.	1991-06-21	101	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