BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter
FDA 510(k) K251654 · Becton Dickinson Infusion Therapy Systems, Inc.
510(k) numberK251654
Submission
- Device name
- BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
Sandy, UT, US - Received
- May 30, 2025
- Decision date
- June 27, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252137 | BD Insyte IV CatheterFOZ · Traditional | 04/02/2026SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | 10/08/2025SE |
| K243403 | BD Nexiva Closed IV Catheter SystemFOZ · Traditional | 07/25/2025SE |
| K251155 | BD Cathena Safety IV CatheterFOZ · Traditional | 07/11/2025SE |
| K250682 | BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV…FOZ · Traditional | 06/03/2025SE |
| K241586 | PIVO Pro Needle-free Blood Collection DeviceJKA · Traditional | 02/27/2025SE |
| K233529 | BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free ConnectorFOZ · Special | 12/01/2023SE |
| K230865 | PIVO Pro Needle-free Blood Collection DeviceJKA · Traditional | 09/28/2023SE |
| K231239 | Nexiva Closed IV Catheter System with NearPort IV AccessFOZ · Traditional | 09/22/2023SE |
| K220584 | BD Cathena Safety IV CatheterFOZ · Special | 03/31/2022SE |
Questions and answers
When was BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter cleared by the FDA?
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter and BD Insyte Autoguard BC Pro Shielded IV Catheter (K251654) received a 510(k) decision of Substantially Equivalent on June 27, 2025, 28 days after the submission was received.
What is the product code of K251654?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.