BD Texium Closed Male Luer
FDA 510(k) K223076 · Care Fusion
510(k) numberK223076
Submission
- Device name
- BD Texium Closed Male Luer
- Applicant
- Care Fusion
San Diego, CA, US - Received
- September 30, 2022
- Decision date
- March 24, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONB – Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
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| K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)ONB · Traditional | Becton, Dickinson and Company | 09/12/2025SE |
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| K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370)ONB · Special | Epic Medical Pte. , Ltd. | 05/29/2025SE |
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| K240517 | ProSeal Vented Universal Vial AdaptorONB · Traditional | Epic Medical Pte. , Ltd. | 12/26/2024SE |
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| K241823 | ToxiSeal Vial AdaptorONB · Special | Epic Medical Pte. , Ltd. | 08/30/2024SE |
More from Epic Medical Pte. , Ltd.
| 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 |
| K223088 | BD SmartSite Needle-Free ConnectorFPA · Traditional | 04/07/2023SE |
| 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 Texium Closed Male Luer cleared by the FDA?
BD Texium Closed Male Luer (K223076) received a 510(k) decision of Substantially Equivalent on March 24, 2023, 175 days after the submission was received.
What is the product code of K223076?
The FDA product code is ONB – Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System, a Class II (moderate risk) device regulated under 21 CFR 880.5440.