Bard Access Systems, Inc.: FDA clearances and approvals
Bard Access Systems, Inc. has 22 FDA 510(k) clearances (first 1993, latest 2025), across 10 product codes in 4 review panels. Median 510(k) review time: 78 days. Since 2017 its median was 43 days, against 106 days for all cleared 510(k)s in the same product codes. openFDA lists 93 product recalls by a recalling firm named Bard Access Systems, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 68 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 179 |
| 2022 | 2 | 29 |
| 2023 | 0 | — |
| 2024 | 3 | 86 |
| 2025 | 2 | 42 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bard Access Systems, Inc.'s cleared 510(k)s took a median 43 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 6 | 6 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 6 | 6 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| DWM | Apparatus, Suction, Patient Care | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| MHC | Needle, Interosseous | 1 | 1 |
| MSD | Catheter, Hemodialysis, Implanted | 1 | 1 |
| PTI | Non-Coring (Huber) Needle | 1 | 1 |
Review panels
- General Hospital (16)
- Radiology (4)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
Most recent Bard Access Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port | LJT | 2025-09-05 | 29 |
| K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port | LJT | 2025-06-18 | 56 |
| K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set | PTI | 2024-11-27 | 198 |
| K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports | LJT | 2024-10-31 | 86 |
| K240146 | BD Prevue II Peripheral Vascular Access System | IYO | 2024-02-18 | 30 |
| K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) | MHC | 2022-11-10 | 28 |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly | LJS | 2022-08-24 | 30 |
| K210264 | BD PowerPiCC Catheter | LJS | 2021-07-30 | 179 |
| K120882 | SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE | IYO | 2012-05-30 | 68 |
| K100402 | SITE-RITE VISION ULTRASOUND SYSTEM | IYN | 2010-03-05 | 17 |
12 earlier clearances. See the full list in Caduvo.
Recalls
93 product recalls in 35 recall events; 19 initiated in the last five years. Most recent: 2026-08-10.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Bard Access Systems, Inc.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Bard Access Systems, Inc. have?
Bard Access Systems, Inc. has 22 FDA 510(k) clearances (first 1993, latest 2025), across 10 product codes in 4 review panels.
How long does FDA take to clear Bard Access Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bard Access Systems, Inc.'s cleared 510(k)s is 78 days. Since 2017: 43 days, versus 106 days for all cleared 510(k)s in the same product codes.
What devices does Bard Access Systems, Inc. make?
Its most frequent FDA product codes are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 6); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 6); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 2).
Has Bard Access Systems, Inc. had device recalls?
openFDA lists 93 product recalls in 35 recall events by a recalling firm whose name matches Bard Access Systems, Inc; the most recent began 2026-08-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 22 Bard Access Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJS, Bard Access Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.