BD SmartSite Needle-Free Connector
FDA 510(k) K223088 · Care Fusion
510(k) numberK223088
Submission
- Device name
- BD SmartSite Needle-Free Connector
- Applicant
- Care Fusion
San Diego, CA, US - Received
- September 30, 2022
- Decision date
- April 7, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access DeviceLHI · Traditional | 03/06/2024SE |
| K231888 | BD Texium Needle-Free SyringeFMF · Traditional | 09/25/2023SE |
| K221327 | BD Alaris Pump Infusion SetsFPA · Traditional | 07/21/2023SE |
| K221319 | BD Alaris Pump Epidural Infusion SetPWH · Traditional | 07/21/2023SE |
| K223101 | BD Secondary Infusion SetFPA · Traditional | 05/12/2023SE |
| K223076 | BD Texium Closed Male LuerONB · Traditional | 03/24/2023SE |
| K201155 | PleurX Peritoneal Catheter SystemPNG · Traditional | 10/21/2020SESK |
| K170405 | BD Curve Ascites ShuntKPM · Traditional | 11/02/2017SESK |
| K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…KNW · Traditional | 09/11/2017SE |
| K153748 | AirLife Misty Finity NebulizerCAF · Traditional | 05/17/2017SE |
Questions and answers
When was BD SmartSite Needle-Free Connector cleared by the FDA?
BD SmartSite Needle-Free Connector (K223088) received a 510(k) decision of Substantially Equivalent on April 7, 2023, 189 days after the submission was received.
What is the product code of K223088?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.