Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bard Access Systems, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
446 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252478 | Vaccess™ CT Low-Profile Power-Injectable Implantable Port; V | Bard Access Systems, Inc. | 2025-09-05 | 29 | 0 |
| K251253 | PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable | Bard Access Systems, Inc. | 2025-06-18 | 56 | 0 |
| K241353 | PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber | Bard Access Systems, Inc. | 2024-11-27 | 198 | 0 |
| K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ C | Bard Access Systems, Inc. | 2024-10-31 | 86 | 0 |
| K240146 | BD Prevue™ II Peripheral Vascular Access System | Bard Access Systems, Inc. | 2024-02-18 | 30 | 0 |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Ass | Bard Access Systems, Inc. | 2022-08-24 | 30 | 0 |
| K210264 | BD PowerPiCC Catheter | Bard Access Systems, Inc. | 2021-07-30 | 179 | 2 |
| K120882 | SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE | Bard Access Systems, Inc. | 2012-05-30 | 68 | 0 |
| K100402 | SITE-RITE VISION ULTRASOUND SYSTEM | Bard Access Systems, Inc. | 2010-03-05 | 17 | 1 |
| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | Bard Access Systems, Inc. | 2007-05-18 | 30 | 0 |
| K053589 | LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING | Bard Access Systems, Inc. | 2006-04-13 | 111 | 0 |
| K053501 | POWERPICC | Bard Access Systems, Inc. | 2006-01-13 | 28 | 0 |
| K051672 | POWERPICC | Bard Access Systems, Inc. | 2005-11-23 | 153 | 0 |
| K050310 | BARDPORT TITANIUM PORTS | Bard Access Systems, Inc. | 2005-04-18 | 69 | 1 |
| K042445 | SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT | Bard Access Systems, Inc. | 2004-10-19 | 40 | 0 |
| K971990 | GESCO PER-Q-CATH PICC CATHETERS | Bard Access Systems, Inc. | 1997-11-07 | 182 | 0 |
| K971991 | GESCO PER-Q-CATH MIDLINE CATHETERS | Bard Access Systems, Inc. | 1997-11-07 | 182 | 0 |
| K935380 | VASCULAR ACCESS CATHETER ACCESSORIES | Bard Access Systems, Inc. | 1995-02-17 | 466 | 0 |
| K926139 | CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH | Bard Access Systems, Inc. | 1995-01-03 | 757 | 0 |
| K926331 | 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH | Bard Access Systems, Inc. | 1994-03-07 | 446 | 1 |
| K924250 | PLASTIC LOW PROFILE SUBCUTANEOUS PORT | Bard Access Systems, Inc. | 1993-10-04 | 406 | 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