Data / Medical devices / United States / Becton Dickinson Infusion Therapy Systems Inc.
Becton Dickinson Infusion Therapy Systems Inc.: FDA-registered device maker in Sandy, UT, United States, 24 510(k) clearances
Becton Dickinson Infusion Therapy Systems Inc. is registered with the FDA (registration 1710034) in Sandy, UT, United States. It lists 8 device types. The FDA files 24 510(k) clearances under its listings, the newest dated April 2, 2026. 17 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1710034
- Address
- 9450 South State Street, Sandy, UT, United States, 84070
- Owner or operator
- Becton Dickinson and Company (9922032)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Specification developer
- First device listed
- July 12, 1991
- Registered through
- 2026
- Brand names listed
- BD Angiocath IV Catheter, BD Cathena Safety IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter with Blood Control Technology, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology, BD Insyte Autoguard Shielded IV Catheter, BD Insyte IV Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Scrub, Operating-Room | GEC | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Contract manufacturer | accessdata.fda.gov |
| I.V. Start Kit | LRS | 2 | Contract sterilizer, Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Contract sterilizer, Manufacturer, Specification developer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2026 | K252137 | BD Insyte IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| October 8, 2025 | K251422 | BD Saf-T-Intima Subcutaneous Catheter System | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| July 25, 2025 | K243403 | BD Nexiva Closed IV Catheter System | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| July 11, 2025 | K251155 | BD Cathena Safety IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| June 27, 2025 | 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 | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| June 3, 2025 | 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 | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| February 27, 2025 | K241586 | PIVO Pro Needle-free Blood Collection Device | JKA | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| December 1, 2023 | K233529 | BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| September 28, 2023 | K230865 | PIVO Pro Needle-free Blood Collection Device | JKA | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| September 22, 2023 | K231239 | Nexiva Closed IV Catheter System with NearPort IV Access | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| March 24, 2023 | K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | JKA | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 31, 2022 | K220584 | BD Cathena Safety IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| February 23, 2021 | K200439 | Velano ExT Extension Set | FPA | Substantially Equivalent | Velano Vascular | accessdata.fda.gov |
| December 18, 2020 | K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter | FOZ | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 20, 2019 | K183399 | BD Nexiva Closed IV Catheter System | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| December 15, 2017 | K173354 | BD Nexiva Diffusics Closed IV Catheter Systems | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| July 27, 2015 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| June 12, 2002 | K020834 | BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I | DYB | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| April 16, 2002 | K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 | FPA | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| December 21, 2001 | K013800 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE | FOZ | Substantially Equivalent | Becton Dickinson Infusion Therapy Systems, Inc. | accessdata.fda.gov |
| June 3, 1998 | K974363 | BECTON DICKINSON BLUNT PLASTIC CANNULA | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 22, 1998 | K974006 | BECTON DICKINSON TWINPAK | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| January 9, 1995 | K942045 | INSYTE INTRODUCER CATHETER | FOZ | Substantially Equivalent | Becton Dickinson Vascular Access, Inc. | accessdata.fda.gov |
| February 12, 1993 | K924439 | BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 21, 2025 | 96865 | Class II | Ongoing | 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. | accessdata.fda.gov |
| April 21, 2025 | 96696 | Class II | Ongoing | 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 | 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. | accessdata.fda.gov |
| June 26, 2024 | 94896 | Class II | Ongoing | 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 patie | Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process. | accessdata.fda.gov |
| October 4, 2023 | 93276 | Class II | Ongoing | 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. | accessdata.fda.gov |
| August 29, 2023 | 92970 | Class II | Ongoing | 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. | accessdata.fda.gov |
| October 12, 2022 | 90972 | Class II | Ongoing | 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). | accessdata.fda.gov |
| November 10, 2021 | 89185 | Class II | Terminated | PIVO Blood Collection Device 20G, REF: | 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. | accessdata.fda.gov |
| September 8, 2021 | 88762 | Class II | Ongoing | 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 T | There is a breach in the product packaging that renders the product non-sterile. | accessdata.fda.gov |
| October 19, 2009 | 53749 | Not yet classified | Terminated | BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc. | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | accessdata.fda.gov |
| July 1, 2005 | 33316 | Not yet classified | Terminated | DTX(tm) Plus DT-DL60 Continuous flush catheter | Device could permit an over-infusion of IV solutions during pressure monitoring procedures. | accessdata.fda.gov |
| July 1, 2005 | 32610 | Not yet classified | Terminated | BD DTX Plus, 60'' complete single-line pressure monitoring kit. | Actuating tab may detach from the stopcock body, allowing fluid leak. | accessdata.fda.gov |
| March 25, 2005 | 31670 | Not yet classified | Terminated | 16 G / 5F Dual Lumen L-Cath catheter only. | Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters. | accessdata.fda.gov |
| February 3, 2005 | 31214 | Not yet classified | Terminated | BD Nexiva Closed IV Catheter System, 18 gauge | The Y-luer connection may crack during normal product use. | accessdata.fda.gov |
| January 10, 2005 | 30864 | Not yet classified | Terminated | BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray | Various procedure trays and kits may have an insufficient seal, thus compromising sterility. | accessdata.fda.gov |
| March 9, 2004 | 28566 | Not yet classified | Terminated | BD L-Cath NN (24ga x 30cm), L-Cath Catheter System | Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion. | accessdata.fda.gov |
| February 3, 2004 | 28397 | Not yet classified | Terminated | BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit. | Splittable catheter introducer may not fully split or may separate non-uniformly. | accessdata.fda.gov |
| April 4, 2003 | 26054 | Not yet classified | Terminated | BD First PICC 3F 65 cm Single Lumen Procedure Kit. | A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Set, Administration, Intravascular
- All makers of Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- All makers of Brush, Scrub, Operating-Room
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Introducer, Catheter
Updated April 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.