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

LYK — Predicate Candidate Screening

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

133 daysmedian FDA review time

254 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253842	Vena MicroAngioscope™ System	Vena Medical Holdings Corp	2026-01-28	57	0
K251767	Vena MicroAngioscope™ System	Vena Medical Holdings Corp	2025-10-01	113	0
K062340	CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM	Cardio-Optics, Inc.	2006-11-30	112	0
K050808	CORONARY SINUS ACCESS KIT, MODEL KCS8F-01	Cardio-Optics, Inc.	2005-07-28	120	0
K011793	KSEA FIBERSCOPE	KARL STORZ Endoscopy-America, Inc.	2002-04-17	313	0
K012724	SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273	Smith & Nephew, Inc.	2001-11-08	86	0
K001408	KSEA VASCULAR FIBERSCOPES	KARL STORZ Endoscopy-America, Inc.	2000-10-30	179	0
K964061	GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)	W. L. Gore & Associates, Inc.	1997-02-20	133	0
K952638	4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTL	Baxter Edwards	1995-07-28	49	0
K951721	APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE	Applied Medical Resources	1995-07-11	88	0
K945591	APPLIED MEDICAL OPTICAL VALVULOTOME	Applied Medical Resources	1995-02-10	88	0
K941715	ULTATHIN FLEXIBLE ENDOSCOPE	Technology Marketing Group	1994-10-04	180	0
K934696	ANGIOSCOPE	Intramed Laboratories, Inc.	1994-01-18	110	0
K931464	BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE	Baxter Healthcare Corp	1993-10-18	208	0
K930758	DIAGNOSTIC INTRAVASCULAR CATHETER	Applied Medical Resources	1993-09-24	224	0
K931421	DISPOSABLE STEERABLE ANGIOSCOPE	Endovascular, Inc.	1993-06-16	86	0
K926433	4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45	Baxter Edwards	1993-03-23	90	0
K924554	CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE	Clarus Medical Systems, Inc.	1993-02-25	169	0
K923996	DISPOSABLE VASCULAR ANGIOSCOPE	Endovascular, Inc.	1993-01-13	156	0
K905745	AMETEC MASY MODULAR ANGIOSCOPE SYSTEM	American Medical Technology, Inc.	1992-04-23	486	0
K914570	DISPOSABLE VASCULAR ANGIOSCOPE	Nobles-Lai	1992-01-27	104	0
K913129	ANGIOLAZ ANGIOSCOPE CATHETER	Angiolaz, Inc.	1991-12-27	164	0
K913763	INTERPRET(TM) CATHETER LINEAR TRANSLATOR	Intertherapy, Inc.	1991-11-20	90	0
K911090	OMEGA ANGIOSCOPES (OMEGASCOPES)	Omega Universal Technologies, Ltd.	1991-07-31	142	0
K911278	OLYMPUS AF ANGIOSCOPE SYSTEM	Olympus Corp.	1991-07-17	114	1
K905083	4.5F IMAGECATH ANGIOSCOPE	Baxter Healthcare Corp	1991-06-21	220	0
K902329	ULTRA-VU ANGIOSCOPE	Angiolaz, Inc.	1990-08-22	90	0
K895538	ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPY	Trimedyne, Inc.	1990-04-26	225	0
K900305	INTRAVASCULAR IMAGING SYSTEMS	Intertherapy, Inc.	1990-04-20	89	0
K897153	CVIS INSIGHT IMAGING CATHETER	Cardiovascular Imaging Systems, Inc.	1990-03-26	90	0
K895159	INTRAVASCULAR IMAGING SYSTEM	Intertherapy, Inc.	1990-03-12	201	0
K894459	ANGIOSCOPE	Intramed Laboratories, Inc.	1990-03-07	232	0
K893816	HEMOLASER HEMOSCOPE	Hemolaser Corp.	1990-02-01	254	0
K890047	VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEM	Vascucare, Inc.	1989-06-20	166	0
K883000	ACS ANGIOSCOPE GUIDE WIRE	Advanced Cardiovascular Systems, Inc.	1988-09-28	72	0
K875108	ACS CORONARY ANGIOSCOPIC CATHETER	Advanced Cardiovascular Systems, Inc.	1988-09-27	288	0
K860858	OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE	Olympus Corp.	1986-11-20	258	0
K842481	AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE	American Edwards Laboratories	1984-10-18	115	0
K834547	ANGIOSCOPY CATHETER	American Edwards Laboratories	1984-06-11	167	0
K832698	ANGIOSCOPY CATHETER	American Edwards Laboratories	1983-11-03	85	0
K830084	ANGIOSCOPE	Trimedyne, Inc.	1983-06-02	142	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