ClearanceBrief
510(k) K201075 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter

ApplicantBecton, Dickinson and Company, Sandy UT, US
DecisionSubstantially Equivalent, Dec 18, 2020
ReceivedApr 22, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K201075

DateFirm and productCodeLinked 510(k)
Jun 23, 2025Becton 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		 FOZNone listed
Jun 23, 2025Becton 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		 FOZNone listed
Jun 23, 2025Becton 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		 FOZNone listed
Jun 23, 2025Becton 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		 FOZNone listed
Jun 23, 2025Becton 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		 FOZNone listed
Jun 23, 2025Becton 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		 FOZNone listed
Jun 23, 2025Becton 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		 FOZNone listed
Jun 23, 2025Becton 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		 FOZNone listed
Jun 23, 2025Becton 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		 FOZNone listed
Jul 31, 2024Becton 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		 FOZNone listed
Nov 24, 2023Becton Dickinson Infusion Therapy Systems Inc.
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
Open, Classified		 FOZNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.