BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device
FDA 510(k) K233021 · Care Fusion
510(k) numberK233021
Submission
- Device name
- BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device
- Applicant
- Care Fusion
San Diego, CA, US - Received
- September 22, 2023
- Decision date
- March 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code LHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252987 | ADRx Admixture DeviceLHI · Traditional | Epic Medical Pte. , Ltd. | 06/12/2026SE |
| K260301 | Vial AdapterLHI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 06/05/2026SE |
| K250345 | Medline Bag DecanterLHI · Traditional | Medline Industries, LP | 10/24/2025SE |
| K251715 | FlowArt® Vial Access Device VentedLHI · Traditional | Asset Medikal | 10/14/2025SE |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II…LHI · Traditional | Microtek Medical, LLC | 09/16/2025SE |
| K243404 | HyHub and HyHub Duo Vial Access DevicesLHI · Traditional | Takeda Pharmaceuticals | 07/18/2025SE |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060)LHI · Traditional | Yukon Medical, LLC | 03/21/2025SE |
| K243985 | Rio Drug Reconstitution Transfer DeviceLHI · Traditional | Icu Medical, Inc. | 01/22/2025SE |
| K243486 | SmartSiteTM Vented Vial Access DeviceLHI · Traditional | Yukon Medical, LLC | 12/06/2024SE |
| K241976 | nextaro® va, 15mm, 5µmLHI · Special | Sfm Medical Devices GmbH | 09/06/2024SE |
More from Sfm Medical Devices GmbH
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K223088 | BD SmartSite Needle-Free ConnectorFPA · Traditional | 04/07/2023SE |
| 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 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device cleared by the FDA?
BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device (K233021) received a 510(k) decision of Substantially Equivalent on March 6, 2024, 166 days after the submission was received.
What is the product code of K233021?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.