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

PNO — Predicate Candidate Screening

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

61 daysmedian FDA review time

257 days90th percentile

45clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260012	UltraScore™ Focused Force PTA Balloon	Bard Peripheral Vascular, Inc.	2026-02-04	30	0
K243944	Aperta NSE PTA Balloon Dilatation Catheter	Goodman Co., Ltd.	2025-04-22	123	0
K242254	D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter	Dk Medical Technology Co., Ltd.	2025-04-21	264	0
K241478	Tri-Wedge PTA Scoring Balloon Dilatation Catheter	Brosmed Medical Co., Ltd.	2024-10-22	151	0
K232258	XO Constrain™ Percutaneous Transluminal Angioplasty Constrai	Transit Scientific, LLC	2024-06-17	322	0
K232013	Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA	Goodman Co., Ltd.	2024-03-28	266	0
K232207	D·Kutting™ PTA Scoring Balloon Dilatation Catheter	Dk Medical Technology Co., Ltd.	2024-03-07	225	0
K221986	XO Score LP Percutaneous Transluminal Angioplasty Scoring Ca	Transit Scientific, LLC	2022-10-18	104	0
K220704	Serranator PTA Serration Balloon Catheter	Cagent Vascular, LLC	2022-05-04	55	0
K213728	Serranator PTA Serration Balloon Catheter	Cagent Vascular, LLC	2021-12-15	19	0
K203437	Serranator PTA Serration Balloon Catheter	Cagent Vascular, LLC	2020-12-22	29	0
K202187	FLEX Vessel Prep System	Venturemed Group, Inc.	2020-09-11	38	0
K193495	XO Score Percutaneous Transluminal Angioplasty Scoring Cathe	Transit Scientific	2020-05-29	164	0
K193181	Serranator PTA Serration Balloon Catheter	Cagent Vascular, LLC	2020-04-15	149	0
K182713	Scoreflex PTA Scoring Balloon Catheter	Orbusneich Medical Trading, Inc.	2019-06-11	257	0
K172571	ULTRASCORE Focused Force PTA Balloon	C. R. Bard	2017-09-22	25	0
K163420	UltraScore Focused Force PTA Balloon	Bard Peripheral Vascular, Inc.	2017-06-14	190	0
K163380	Serranator Alto PTA Serration Balloon Catheter	Cagent Vascular, LLC	2017-02-13	74	0
K152789	FLEX SCORING CATHETER	Venturemed Group	2016-05-25	243	0
K151253	2cm Peripheral Cutting Balloon Microsurgical Dilatation Cath	Boston Scientific Limited	2015-06-10	29	0
K150634	AngioSculpt PTA Scoring Baloon Catheters	Spectranetrics	2015-04-08	28	0
K141322	ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER	Cook Incorporated	2015-03-27	311	3
K142983	AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coa	Angioscore, Inc.	2015-03-04	139	0
K133998	ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING	Angioscore, Inc.	2014-04-18	113	0
K122685	ANGIOSCULPT PTA SCORING BALLOON CATHETER	Angioscore, Inc.	2013-01-11	133	0
K113103	SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVI	Rex Medical	2012-05-22	216	0
K112182	ANGIOSCULPT PTA SCORING BALLOON CATHETER	Angioscore, Inc.	2011-08-26	29	0
K110767	ANGIOSCULPT PTA SCORING BALLOON CATHETER	Angioscore, Inc.	2011-04-15	28	0
K103459	VASCUTRAK PTA DILATATION CATHETER	C.R. Bard, Inc.	2010-12-13	19	0
K101735	ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 21	Angioscore, Inc.	2010-07-14	23	0
K100303	ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 20	Angioscore, Inc.	2010-03-22	47	0
K091966	ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040,	Angioscore, Inc.	2009-07-30	29	0
K082343	VASCUTRAK 2, MODELS: V14 AND V18	Ymed, Inc.	2008-09-11	27	0
K082059	ANGIOSCULPT PTA SCORING BALLOON CATHETER	Angioscore, Inc.	2008-08-11	21	0
K081220	MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER	Angioscore, Inc.	2008-05-28	28	0
K080151	ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 20	Angioscore, Inc.	2008-04-25	94	5
K073025	VASCUTRAK II PTA DILATATION CATHETER	Thermopeutix, Inc. Dba Ymed, Inc.	2007-11-09	14	0
K072225	ANGIOSCULPT PTA SCORING BALLOON CATHETER	Angioscore, Inc.	2007-10-12	63	5
K070951	2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BAL	Boston Scientific	2007-06-04	61	0
K063657	VASCUTRAK PTA DILATION CATHETER	Ymed, Inc.	2006-12-12	4	0
K062387	SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM	Boston Scientific	2006-10-05	51	0
K050629	ANGIOSCULPT SCORING BALLOON CATHETER	Angioscore, Inc.	2005-09-02	175	0
K051254	PERIPHERAL CUTTING BALLOON	Boston Scientific Ivt	2005-06-22	37	0
K041993	2 CM PERIPHERAL CUTTING BALOON	Boston Scientific Ivt	2004-08-16	24	0
K040155	PERIPHERAL CUTTING BALLOON	Boston Scientific Corp	2004-07-01	160	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