Becton Dickinson Infusion Therapy Systems Inc.
Sandy, UT, US
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. appears in FDA device records in Sandy, UT. FDA records list 44 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 72 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Becton Dickinson Infusion Therapy Systems Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Becton Dickinson Infusion Therapyrecall
- Becton Dickinson Medical Systemsrecall
- Velano Vascular, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 44 510(k) clearances for Becton Dickinson Infusion Therapy Systems Inc. between 1997 and 2026. The busiest year on record is 2025, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 4 |
| 1998 | 1 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 3 |
| 2004 | 2 |
| 2005 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 2 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2025 | 6 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252137 | BD Insyte™ IV Catheter | FOZ | Substantially Equivalent | |
| K251422 | BD Saf-T-Intima™ Subcutaneous Catheter System | FOZ | Substantially Equivalent | |
| K243403 | BD Nexiva™ Closed IV Catheter System | FOZ | Substantially Equivalent | |
| K251155 | BD Cathena™ Safety IV Catheter | FOZ | Substantially Equivalent | |
| K251654 | BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter | FOZ | Substantially Equivalent | |
| K250682 | BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector | FOZ | Substantially Equivalent | |
| K241586 | PIVO™ Pro Needle-free Blood Collection Device | JKA | Substantially Equivalent | |
| K233529 | BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector | FOZ | Substantially Equivalent | |
| K230865 | PIVO™ Pro Needle-free Blood Collection Device | JKA | Substantially Equivalent | |
| K231239 | Nexiva™ Closed IV Catheter System with NearPort™ IV Access | FOZ | Substantially Equivalent | |
| K201237 | Velano Vascular Blood Collection Adapter | JKA | Substantially Equivalent | |
| K220584 | BD Cathena Safety IV Catheter | FOZ | Substantially Equivalent | |
| K200439 | Velano ExT Extension Set | FPA | Substantially Equivalent | |
| K201717 | BD Cathena Safety IV Catheter | FOZ | Substantially Equivalent | |
| K192493 | BD Cathena (TM) Safety IV Catheter | FOZ | Substantially Equivalent | |
| K193569 | PIVO(TM) | JKA | Substantially Equivalent | |
| K190604 | PIVO | JKA | Substantially Equivalent | |
| K182897 | Velano Vascular Q2 Extension Set | FPA | Substantially Equivalent | |
| K183399 | BD Nexiva Closed IV Catheter System | FOZ | Substantially Equivalent | |
| K173354 | BD Nexiva Diffusics Closed IV Catheter Systems | FOZ | Substantially Equivalent | |
| K163508 | PIVO | JKA | Substantially Equivalent | |
| K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems | FOZ | Substantially Equivalent | |
| K152924 | TIVA¿ | JKA | Substantially Equivalent | |
| K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | FOZ | Substantially Equivalent | |
| K143610 | BD INTIMA II CLOSED IV CATHETER | FOZ | Substantially Equivalent | |
| K142946 | TIVA | JKA | Substantially Equivalent | |
| K123734 | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM | FOZ | Substantially Equivalent | |
| K102520 | BD NEXIVA CLOSED IV CATHETER SYSTEM | FOZ | Substantially Equivalent | |
| K100775 | BD INTIMA II CLOSED IV CATHETER | FOZ | Substantially Equivalent | |
| K050207 | BD POSIFLOW POSITIVE DISPLACEMENT VALVE | FPA | Substantially Equivalent | |
| K042862 | BD ONECATH | FOZ | Substantially Equivalent | |
| K032843 | NEXIVA CLOSED IV CATHETER SYSTEM | FOZ | Substantially Equivalent | |
| K020834 | BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I | DYB | Substantially Equivalent | |
| K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 | FPA | Substantially Equivalent | |
| K013304 | BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER | DBY | Substantially Equivalent | |
| K013800 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE | FOZ | Substantially Equivalent | |
| K013073 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS | FOZ | Substantially Equivalent | |
| K002033 | BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS | FOZ | Substantially Equivalent | |
| K000235 | INSYTE CATHETER, INSYTE AUTOGUARD CATHETER | FOZ | Substantially Equivalent | |
| K974764 | INTROSYTE CATHETER | FOZ | Substantially Equivalent | |
| K972264 | FIRST MIDCATH CATHETER | FOZ | Substantially Equivalent | |
| K972263 | FIRST PICC CATHETER WITH DUAL LUMENS | FOZ | Substantially Equivalent | |
| K972262 | FIRST PICC CATHETER | FOZ | Substantially Equivalent | |
| K972254 | FIRST MIDCATH CATHETER | FOZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1710034 | 1710034 | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 9450 South State Street, Sandy, UT 84070 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GECBrush, Scrub, Operating-Room
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- DBYFab, Rhodamine, Antigen, Antiserum, Control
- LRSI.V. Start Kit
- DYBIntroducer, Catheter
- FMINeedle, Hypodermic, Single Lumen
- FPASet, Administration, Intravascular
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
Showing 25 of 72| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2007-2025 | REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | Class II | Open, Classified | |
| Z-2006-2025 | REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | Class II | Open, Classified | |
| Z-2005-2025 | REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | Class II | Open, Classified | |
| Z-2004-2025 | REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | Class II | Open, Classified | |
| Z-2003-2025 | REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | Class II | Open, Classified | |
| Z-2002-2025 | REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | Class II | Open, Classified | |
| Z-2001-2025 | REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | Class II | Open, Classified | |
| Z-2000-2025 | REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | Class II | Open, Classified | |
| Z-1999-2025 | REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY | Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. | Class II | Open, Classified | |
| Z-1808-2025 | BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862 | Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay. | Class II | Open, Classified | |
| Z-2458-2024 | BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. | Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process. | Class II | Open, Classified | |
| Z-0400-2024 | BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533 | Over-the-needle, intravascular catheters may have needles that do not retract properly into the barrel, which could result in contaminated needlestick injury, blood leaking from the insertion site or catheter, and repeat catheter insertion attempts, due to catheter being inadvertently removed from the insertion site. | Class II | Open, Classified | |
| Z-0025-2024 | REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO | There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed. | Class II | Open, Classified | |
| Z-0174-2023 | BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr) | During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip exposed). | Class II | Open, Classified | |
| Z-0527-2022 | PIVO Blood Collection Device 20G, REF: 202-0005 | Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection. | Class II | Terminated | |
| Z-0306-2022 | BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, vent plug and pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. A BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash" Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and dual port adapter are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | There is a breach in the product packaging that renders the product non-sterile. | Class II | Open, Classified | |
| Z-0840-2010 | BD Nexiva Closed IV Catheter System, REF 383649, 18GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | Terminated | ||
| Z-0839-2010 | BD Nexiva Closed IV Catheter System, REF 383647, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | Terminated | ||
| Z-0838-2010 | BD Nexiva Closed IV Catheter System, REF 383540, 18GA 1.75IN, Becton Dickinson Infusion Therapy Systems Inc. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | Terminated | ||
| Z-0837-2010 | BD Nexiva Closed IV Catheter System, REF 383539, 18GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | Terminated | ||
| Z-0836-2010 | BD Nexiva Closed IV Catheter System, REF 383538, 20GA 1.75IN, Becton Dickinson Infusion Therapy Systems Inc. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | Terminated | ||
| Z-0835-2010 | BD Nexiva HF Closed IV Catheter System, REF 383537, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | Terminated | ||
| Z-0834-2010 | BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | Terminated | ||
| Z-0833-2010 | BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN, Becton Dickinson Infusion Therapy Systems Inc. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | Terminated | ||
| Z-0832-2010 | BD Nexiva Closed IV Catheter System, REF 383533, 20GA 1.00IN, Becton Dickinson Infusion Therapy Systems Inc. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain