510(k) K231286

Chemfort® Catheter Adaptor by Simplivia Healthcare , Ltd. — Product Code ONB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 2, 2023
Date Received: May 4, 2023
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 Simplivia Healthcare , Ltd.

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K201142 — TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR (February 25, 2021)
K192866 — Chemfort CSTD (May 7, 2020)

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)