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

C.R. Bard, Inc. — Predicate Candidate Screening

646 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

77 daysmedian FDA review time

227 days90th percentile

646clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253514	Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 Fre	C.R. Bard, Inc.	2026-07-10	246	0
K254076	BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter K	C.R. Bard, Inc.	2026-05-29	162	0
K252971	Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fi	C.R. Bard, Inc.	2026-03-17	181	0
K251864	Rubber Utility Catheter	C.R. Bard, Inc.	2026-02-23	251	0
K251186	Bard® Temporary Pacing Electrode Catheter Needle / Cannula (	C.R. Bard, Inc.	2025-05-15	29	0
K241334	Semi-Floating Temporary Pacing Electrode Catheter, Bipolar,	C.R. Bard, Inc.	2025-01-31	266	0
K230356	Aspirex™ Thrombectomy System	C.R. Bard, Inc.	2023-03-31	50	0
K223177	Highlander™ 014 PTA Balloon Dilatation Catheter	C.R. Bard, Inc.	2023-01-20	101	0
K222793	WavelinQ™ Generator	C.R. Bard, Inc.	2022-10-17	31	0
K220270	Aspirex Thrombectomy System	C.R. Bard, Inc.	2022-06-21	141	0
K213203	Provena(TM) Midline Catheter	C.R. Bard, Inc.	2022-05-13	226	1
K212588	Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatati	C.R. Bard, Inc.	2022-05-04	261	0
K212708	Halo One Thin-Walled Guiding Sheath	C.R. Bard, Inc.	2021-09-23	28	0
K211738	Rotarex Atherectomy System	C.R. Bard, Inc.	2021-09-14	99	1
K203363	Crosser iQ CTO Recanalization System	C.R. Bard, Inc.	2021-08-12	269	1
K203575	GlidePath Retro Long-Term Hemodialysis Catheter	C.R. Bard, Inc.	2021-07-01	206	0
K201452	Groshong NXT PICC Catheter	C.R. Bard, Inc.	2021-03-12	284	1
K203275	Recon Support Catheter	C.R. Bard, Inc.	2021-03-01	115	0
K202150	GlidePath 7.5F Long-Term Dialysis Catheter	C.R. Bard, Inc.	2020-11-18	107	0
K200818	3DMax MID Anatomical Mesh	C.R. Bard, Inc.	2020-07-17	109	0
K200627	GlidePath 10F Long-Term Dialysis Catheter	C.R. Bard, Inc.	2020-06-22	104	0
K191532	The Caterpillar and Caterpillar Micro Arterial Embolization	C.R. Bard, Inc.	2020-02-04	239	0
K192313	Halo One Thin-Walled Guiding Sheath	C.R. Bard, Inc.	2019-12-19	115	0
K192239	WavelinQ Plus EndoAVF System	C.R. Bard, Inc.	2019-10-17	59	1
K191232	AccuCath Ace Intravascular Catheter	C.R. Bard, Inc.	2019-09-18	133	0
K191143	PowerFlow Implantable Apheresis IV Port	C.R. Bard, Inc.	2019-08-02	94	0
K181446	Bard Power-Injectable Implantable Ports (PowerPorts®)	C.R. Bard, Inc.	2019-07-08	402	0
K190185	Phasix ST Mesh with Open Positioning System	C.R. Bard, Inc.	2019-06-12	131	0
K182796	WavelinQ 4F EndoAVF System	C.R. Bard, Inc.	2019-02-06	128	0
K182008	Phasix ST Mesh with Echo 2 Positioning System	C.R. Bard, Inc.	2018-12-14	140	0
K180781	Bard Vertus Foley Catheter	C.R. Bard, Inc.	2018-09-19	177	0
K181323	Atlas Gold PTA Dilatation Catheter	C.R. Bard, Inc.	2018-08-03	77	0
K180560	Sherlock 3CG+ T ip Confirmation System	C.R. Bard, Inc.	2018-06-18	109	0
K173143	Phasix ST Mesh	C.R. Bard, Inc.	2018-04-25	208	0
K172511	Hickman TriFusion Catheter	C.R. Bard, Inc.	2018-04-20	242	0
K172932	True Flow Valvuloplasty Perfusion Catheter	C.R. Bard, Inc.	2017-12-13	78	0
K172397	Sherlock 3CG Tip Positioning System Stylet	C.R. Bard, Inc.	2017-09-29	52	0
K172247	Magic3 Go Intermittent Urinary Catheter	C.R. Bard, Inc.	2017-09-20	56	2
K171735	PowerLoc MAX Power-Injectable Infusion Set and SafeStep Hube	C.R. Bard, Inc.	2017-08-08	57	0
K163216	Pinpoint GT Needles	C.R. Bard, Inc.	2017-06-27	223	0
K163437	hypodermic Pinpoint™ GT Needle	C.R. Bard, Inc.	2017-06-23	198	0
K170158	PowerGlide ST Midline Catheter	C.R. Bard, Inc.	2017-06-01	134	0
K170278	OptiFix AT Absorbable Fixation System with Articulating Tech	C.R. Bard, Inc.	2017-05-31	121	0
K171348	Pinpoint GT Needle Guide Kits	C.R. Bard, Inc.	2017-05-22	14	0
K162441	PowerPICC Provena Catheters with SOLO Valve Technology	C.R. Bard, Inc.	2017-04-24	236	0
K163001	PowerFlow Apheresis I.V. Port	C.R. Bard, Inc.	2017-04-17	171	0
K163698	OptiFix Open Absorbable Fixation System - 20 absorbable fast	C.R. Bard, Inc.	2017-04-11	103	0
K163458	Zenysis Short-Term Dialysis Catheter	C.R. Bard, Inc.	2017-04-04	116	0
K162900	PowerMidline Catheter	C.R. Bard, Inc.	2016-12-14	58	1
K162894	AccuCath Intravascular Catheter	C.R. Bard, Inc.	2016-11-15	29	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