510(k) K223076

BD Texium Closed Male Luer by Care Fusion — Product Code ONB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 24, 2023
Date Received: September 30, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class: Class II
Regulation Number: 880.5440
Review Panel: HO
Submission Type

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

Other clearances by Care Fusion

K233021 — BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device (March 6, 2024)
K231888 — BD Texium Needle-Free Syringe (September 25, 2023)
K221319 — BD Alaris Pump Epidural Infusion Set (July 21, 2023)
K221327 — BD Alaris Pump Infusion Sets (July 21, 2023)
K223101 — BD Secondary Infusion Set (May 12, 2023)
K223088 — BD SmartSite Needle-Free Connector (April 7, 2023)
K201155 — PleurX Peritoneal Catheter System (October 21, 2020)
K170405 — BD Curve Ascites Shunt (November 2, 2017)
K171531 — Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Bio (September 11, 2017)
K153748 — AirLife Misty Finity Nebulizer (May 17, 2017)

Other clearances for product code ONB

K251722 — ProSeal Transfer Injector (421120, 421130, 421140) (December 5, 2025)
K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (October 21, 2025)
K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) (September 12, 2025)
K251411 — Chemfort Female Luer Lock Adaptor (August 5, 2025)
K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370) (May 29, 2025)
K243976 — ZeroClear Bag Access (423100) (January 22, 2025)
K240517 — ProSeal Vented Universal Vial Adaptor (December 26, 2024)
K241988 — ProSeal Closed System Bag Access (October 23, 2024)
K241735 — ProSeal In Line Pump Set (423850) (October 10, 2024)
K241823 — ToxiSeal Vial Adaptor (August 30, 2024)