Company · US
Becton Dickinson Infusion Therapy Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2026. Name variants (Inc, Corp, punctuation) are merged.
36510(k) clearances (1 in 12 months)
15recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2026 | K252137 | BD Insyte IV Catheter Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Oct 8, 2025 | K251422 | BD Saf-T-Intima Subcutaneous Catheter System Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jul 25, 2025 | K243403 | BD Nexiva Closed IV Catheter System Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jul 11, 2025 | K251155 | BD Cathena Safety IV Catheter Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jun 27, 2025 | K251654 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC P Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jun 3, 2025 | K250682 | BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Nee Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Feb 27, 2025 | K241586 | PIVO Pro Needle-free Blood Collection Device Becton Dickinson Infusion Therapy Systems, Inc. | JKA |
| Dec 1, 2023 | K233529 | BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Sep 28, 2023 | K230865 | PIVO Pro Needle-free Blood Collection Device Becton Dickinson Infusion Therapy Systems, Inc. | JKA |
| Sep 22, 2023 | K231239 | Nexiva Closed IV Catheter System with NearPort IV Access Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Mar 31, 2022 | K220584 | BD Cathena Safety IV Catheter Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Sep 22, 2020 | K201717 | BD Cathena Safety IV Catheter Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jan 24, 2020 | K192493 | BD Cathena (TM) Safety IV Catheter Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Mar 20, 2019 | K183399 | BD Nexiva Closed IV Catheter System Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Dec 15, 2017 | K173354 | BD Nexiva Diffusics Closed IV Catheter Systems Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Aug 29, 2016 | K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jul 27, 2015 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Apr 9, 2015 | K143610 | BD INTIMA II CLOSED IV CATHETER Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jan 17, 2013 | K123734 | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jan 6, 2011 | K102520 | BD NEXIVA CLOSED IV CATHETER SYSTEM Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jun 3, 2010 | K100775 | BD INTIMA II CLOSED IV CATHETER Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Apr 7, 2005 | K050207 | BD POSIFLOW POSITIVE DISPLACEMENT VALVE Becton Dickinson Infusion Therapy Systems, Inc. | FPA |
| Dec 3, 2004 | K042862 | BD ONECATH Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Feb 27, 2004 | K032843 | NEXIVA CLOSED IV CATHETER SYSTEM Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jun 12, 2002 | K020834 | BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I Becton Dickinson Infusion Therapy Systems, Inc. | DYB |
| Apr 16, 2002 | K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 Becton Dickinson Infusion Therapy Systems, Inc. | FPA |
| Jan 2, 2002 | K013304 | BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER Becton Dickinson Infusion Therapy Systems, Inc. | DBY |
| Dec 21, 2001 | K013800 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Nov 8, 2001 | K013073 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Jul 26, 2000 | K002033 | BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Apr 5, 2000 | K000235 | INSYTE CATHETER, INSYTE AUTOGUARD CATHETER Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Feb 26, 1998 | K974764 | INTROSYTE CATHETER Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Sep 15, 1997 | K972264 | FIRST MIDCATH CATHETER Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Sep 15, 1997 | K972263 | FIRST PICC CATHETER WITH DUAL LUMENS Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Sep 15, 1997 | K972262 | FIRST PICC CATHETER Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
| Sep 12, 1997 | K972254 | FIRST MIDCATH CATHETER Becton Dickinson Infusion Therapy Systems, Inc. | FOZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. REF: 381434
BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly Open, Classified |
FOZ | K201075 |
| Jun 23, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. 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 Open, Classified |
FOZ | K201075 |
| Jun 23, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. REF: 382544
BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly Open, Classified |
FOZ | K201075 |
| Jun 23, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. 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 Open, Classified |
FOZ | K201075 |
| Jun 23, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. 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 Open, Classified |
FOZ | K201075 |
| Jun 23, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly Open, Classified |
FOZ | K201075 |
| Jun 23, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly Open, Classified |
FOZ | K201075 |
| Jun 23, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. 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 Open, Classified |
FOZ | K201075 |
| Jun 23, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY Open, Classified |
FOZ | K201075 |
| May 21, 2025 | Becton Dickinson Infusion Therapy Systems, Inc. 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 Te Open, Classified |
FOZ | K220584 |
| Jul 31, 2024 | Becton Dickinson Infusion Therapy Systems, Inc. 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 i Open, Classified |
FOZ | K201075 |
| Nov 24, 2023 | Becton Dickinson Infusion Therapy Systems Inc. BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533 Open, Classified |
FOZ | K201075 |
| Oct 3, 2023 | Becton Dickinson Infusion Therapy Systems Inc. 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 Open, Classified |
FOZ | K220584 |
| Nov 3, 2022 | Becton Dickinson Infusion Therapy Systems Inc. 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) Open, Classified |
FOZ | K183399 |
| Sep 8, 2021 | Becton Dickinson Infusion Therapy Systems Inc. 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 Open, Classified |
FOZ | K183399 |