Company · US
Bard Access Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2025. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
93recalls (17 in 12 months)
73recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 45 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 10 |
| ITX | Transducer, Ultrasonic, Diagnostic | 8 |
| FPA | Set, Administration, Intravascular | 6 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 5 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 4 |
| KGC | Tube, Gastro-Enterostomy | 4 |
| KMK | Device, Intravascular Catheter Securement | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 3 |
| PND | Midline Catheter | 3 |
| PXI | Thoracentesis Tray | 3 |
| DYB | Introducer, Catheter | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 |
| MPB | Catheter, Hemodialysis, Non-Implanted | 2 |
| MSD | Catheter, Hemodialysis, Implanted | 2 |
| NIE | Catheter, Hemodialysis, Triple Lumen, Non-Implanted | 2 |
| DQY | Catheter, Percutaneous | 1 |
| DWM | Apparatus, Suction, Patient Care | 1 |
| FRO | Dressing, Wound, Drug | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 5, 2025 | K252478 | Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo Bard Access Systems, Inc. | LJT |
| Jun 18, 2025 | K251253 | PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R. Bard Access Systems, Inc. | LJT |
| Nov 27, 2024 | K241353 | PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set Bard Access Systems, Inc. | PTI |
| Oct 31, 2024 | K242328 | PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports Bard Access Systems, Inc. | LJT |
| Feb 18, 2024 | K240146 | BD Prevue II Peripheral Vascular Access System Bard Access Systems, Inc. | IYO |
| Nov 10, 2022 | K223198 | BD Intraosseous Vascular Access System EMS Powered Driver (D001003) Bard Access Systems | MHC |
| Aug 24, 2022 | K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly Bard Access Systems, Inc. | LJS |
| Jul 30, 2021 | K210264 | BD PowerPiCC Catheter Bard Access Systems, Inc. | LJS |
| May 30, 2012 | K120882 | SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE Bard Access Systems, Inc. | IYO |
| Mar 5, 2010 | K100402 | SITE-RITE VISION ULTRASOUND SYSTEM Bard Access Systems, Inc. | IYN |
| May 18, 2007 | K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM Bard Access Systems, Inc. | DWM |
| Apr 13, 2006 | K053589 | LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING Bard Access Systems, Inc. | MSD |
| Jan 13, 2006 | K053501 | POWERPICC Bard Access Systems, Inc. | LJS |
| Nov 23, 2005 | K051672 | POWERPICC Bard Access Systems, Inc. | LJS |
| Apr 18, 2005 | K050310 | BARDPORT TITANIUM PORTS Bard Access Systems, Inc. | LJT |
| Oct 19, 2004 | K042445 | SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT Bard Access Systems, Inc. | ITX |
| Nov 7, 1997 | K971991 | GESCO PER-Q-CATH MIDLINE CATHETERS Bard Access Systems, Inc. | FOZ |
| Nov 7, 1997 | K971990 | GESCO PER-Q-CATH PICC CATHETERS Bard Access Systems, Inc. | FOZ |
| Feb 17, 1995 | K935380 | VASCULAR ACCESS CATHETER ACCESSORIES Bard Access Systems, Inc. | LJS |
| Jan 3, 1995 | K926139 | CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH Bard Access Systems, Inc. | LJT |
| Mar 7, 1994 | K926331 | 3.0 FR GROSHONG PERIPHER INSERT CENT VENOUS CATH Bard Access Systems, Inc. | LJS |
| Oct 4, 1993 | K924250 | PLASTIC LOW PROFILE SUBCUTANEOUS PORT Bard Access Systems, Inc. | LJT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Bard Access Systems, Inc. DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150;
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200;
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240;
DuoGlide Short Open, Classified |
MPB | K030268 K090102 |
| Sep 11, 2026 | Bard Access Systems, Inc. Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150;
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200;
Power-Trialysis Short-Term Straight Dialysis Catheter, REF: Open, Classified |
MPB | K133456 K141531 |
| Aug 14, 2026 | Bard Access Systems, Inc. BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK,
BD Needle Kit for Powered Driver 25mm x 15Ga, REF: D015251NK,
BD Needle Kit for Powered Driver 35mm x 15Ga, REF: D015351NK,
BD Needle Kit Open, Classified |
FMI | K191976 K203193 |
| Jul 2, 2026 | Bard Access Systems, Inc. 4380 ECONOMY SOFT TISSUE BIOPSY TRAY
UDI-DI Code: 0110885403108563
4382A SOFT TISSUE BIOPSY TRAY
UDI-DI Code: 0110885403108501
The Soft Tissue Biopsy devices are indicated for use in the collection Open, Classified |
FSH | K813338 |
| Jul 2, 2026 | Bard Access Systems, Inc. CK000880 Provena Midline Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741188770
S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen
UDI-DI Code: 00801741154003
S4153108BP Provena Midline Catheter 3 Open, Classified |
PND | K213203 |
| Jul 2, 2026 | Bard Access Systems, Inc. 1174108 PowerPICC Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741154935
1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen
UDI-DI Code: 00801741034602
1174108D3 PowerPICC Catheter 4 Fr Single-Lumen
UD Open, Classified |
LJS | K210264 |
| Jul 2, 2026 | Bard Access Systems, Inc. 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741035258
The Groshong NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to Open, Classified |
LJS | K201452 |
| Jul 2, 2026 | Bard Access Systems, Inc. CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741236129
CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741188800
CK000884A PowerPICC Provena SOLO Open, Classified |
LJS | K180548 |
| Jul 2, 2026 | Bard Access Systems, Inc. CK000980A PowerMidline Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741236150
P4254108 PowerMidline Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741129278
P4254108D PowerMidline Catheter 4 Fr Dual-Lumen Open, Classified |
PND | K162900 |
| Jul 2, 2026 | Bard Access Systems, Inc. CK000727 PowerMidline Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741138478
CK000729 PowerMidline Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741138713
P4153108D PowerMidline Catheter 3 Fr Single- Open, Classified |
PND | K153393 |
| Jul 2, 2026 | Bard Access Systems, Inc. 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen
UDI-DI Code: 00801741107177
5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Tr Open, Classified |
NIE | K141531 |
| Jul 2, 2026 | Bard Access Systems, Inc. 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen
UDI-DI Code: 00801741086953
5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen
UDI-DI Co Open, Classified |
NIE | K133456 |
| Jul 2, 2026 | Bard Access Systems, Inc. 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110
3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536
The PowerPlCC SV catheters are intended for short or Open, Classified |
LJS | K102159 |
| Jul 2, 2026 | Bard Access Systems, Inc. CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen
UDI-DI Code: 00801741129674
Catheter stylets provide internal reinforcement to aid in catheter placement. Open, Classified |
LJS | K091324 |
| Jul 2, 2026 | Bard Access Systems, Inc. 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen
UDI-DI Code: 00801741042119
The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than Open, Classified |
PXI | K030268 |
| Jul 2, 2026 | Bard Access Systems, Inc. CK000495A Poly Midline Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741121609
CK000566 Poly Midline Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741108051
CK000566 Poly Midline Catheter 4 Fr Single- Open, Classified |
PXI | K001901 |
| Jul 2, 2026 | Bard Access Systems, Inc. OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED
UDI-DI Code: 0110885403284748
PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM
UDI-DI Code: 0110885403108365
TPT1000 THORACENTESIS/PARACENTESIS TRAY
UDI-DI Code: 011 Open, Classified |
PXI | None listed |
| Apr 16, 2025 | Bard Access Systems, Inc. BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 217 Open, Classified |
LJS | K210264 |
| Jul 22, 2022 | Bard Access Systems, Inc. Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga,
D015151MK/ BD Manual Driver Needle Kit 15mm x 15Ga,
D015251NK/ BD Needle Kit for Power Open, Classified |
FMI | K191976 K203193 |
| May 19, 2021 | Bard Access Systems Inc. 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with 70 cm Guidewire
Unit Label:
PowerPICC REF CK000340B BARD MYPICC KIT 5F French Size Dual-Lumen 70cm Guidewire Terminated |
LJS | None listed |
| May 19, 2021 | Bard Access Systems Inc. 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire
Instructions For Use:
PowerPicc Polyurethand Radiology PiCC with Microintroducer Terminated |
LJS | K051672 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617407, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035248 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617405, Groshong NXT ClearVue Catheter Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741086998 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for u Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF CK000379, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, CE 2797, UDI: (01)10801741102704 - Product Usage: is designed for use when Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 91660417, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Tip, Basic Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107822 - Product Usage: is designed Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 69655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741147521 - Product Usage: is designed for use when central Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 9655405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036023 - Product Usage: is designed for use when central Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 9617408D, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Maximal Barrier Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036016 - Product Usage: is designed for use wh Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 9617408, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741036009 - Product Usage: is designed for use when central v Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 9617407, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Full Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035996 - Product Usage: is designed for use when central v Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 9617405, Groshong NXT ClearVue Catheter with Sherlock Tip Location System (TLS) Stylet, Basic Kit, 4F, Single-Lumen, TLS, UDI: (01)10801741035989 - Product Usage: is designed for use when central Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7655405J, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200615 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7655405, Groshong NXT ClearVue Catheter, Basic Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035279 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for use when central venous catheterization is prescrib Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Apr 7, 2021 | Bard Access Systems Inc. REF 7617400, Groshong NXT ClearVue Catheter, intermediate kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741045094 - Product Usage: is designed for use when central venous catheterization is prescribed. Terminated |
LJS | K063240 K201452 |
| Feb 6, 2018 | Bard Access Systems Inc. PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration. Terminated |
LJS | K162443 |
| May 19, 2017 | Bard Access Systems Inc. StatLock IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 dev Terminated |
KMK | None listed |
| Jan 10, 2017 | Bard Access Systems SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as single units in thermoformed trays. There are 25 SafeStep trays per case and 100 per carton.
Product Usage:
Inten Terminated |
FPA | K040527 |
| Jan 10, 2017 | Bard Access Systems MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Packaged as single units in thermoformed trays. There are 20 MiniLoc trays per case and 160 per carton.
Product U Terminated |
FPA | K050600 |
| Jan 10, 2017 | Bard Access Systems StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or 5 Terminated |
KMK | None listed |
| Jan 10, 2017 | Bard Access Systems StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 2 Terminated |
KMK | None listed |
| Sep 23, 2015 | Bard Access Systems Marketing brochures for the PowerPICC and PowerPICC SOLO catheters Terminated |
LJS | None listed |
| Jul 8, 2015 | Bard Access Systems PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock)
The PowerPICC Solo catheters are intended for short or long term peripheral access to the central ve Terminated |
LJS | K072230 K091324 |
| Jul 8, 2015 | Bard Access Systems PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain)
The PowerPICC Solo catheters are intended for short or long term peripheral acc Terminated |
LJS | K072230 K091324 |
| Jul 8, 2015 | Bard Access Systems PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer
The PowerPICC Solo catheters are intended for short or long term peripheral access to the central Terminated |
LJS | K072230 K091324 |
| Jul 8, 2015 | Bard Access Systems PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer
The PowerPICC Solo catheters are intended for short or long term peripheral access to the central v Terminated |
LJS | K072230 K091324 |
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