FDA 510(k) Applications for Medical Device Product Code "ONB"
(Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K123213 | BECTON DICKINSON & CO. | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE | 01/09/2013 |
| K140591 | BECTON DICKINSON & CO. | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR | 05/14/2014 |
| K130197 | Becton, Dickinson and Company | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 | 02/27/2013 |
| K201099 | Becton, Dickinson and Company | BD PhaSeal Optima Closed System Drug Transfer Device | 08/12/2020 |
| K181221 | Becton, Dickinson and Company | BD PhaSeal Optima Closed System Transfer Device | 11/30/2018 |
| K223076 | CareFusion | BD TexiumÖ Closed Male Luer | 03/24/2023 |
| K222929 | Epic Medical Pte Ltd | ToxiSeal Vial Adapter with External Balloon | 01/11/2024 |
| K251340 | Epic Medical Pte. Ltd. | ProSealÖ Bag Spike with Additive Port (423370ST, 423370) | 05/29/2025 |
| K241988 | Epic Medical Pte. Ltd. | ProSealÖ Closed System Bag Access | 10/23/2024 |
| K192075 | Epic Medical Pte. Ltd. | ProSealÖ Closed System drug Transfer Device (CSTD) | 08/07/2020 |
| K241735 | Epic Medical Pte. Ltd. | ProSealÖ In Line Pump Set (423850) | 10/10/2024 |
| K240433 | Epic Medical Pte. Ltd. | ProSealÖ Injection Site Extended Male Luer Lock (422140) | 05/21/2024 |
| K240171 | Epic Medical Pte. Ltd. | ProSealÖ Injector Plus (Model no. 421050) | 03/28/2024 |
| K240517 | Epic Medical Pte. Ltd. | ProSealÖ Vented Universal Vial Adaptor | 12/26/2024 |
| K241823 | Epic Medical Pte. Ltd. | ToxiSealÖ Vial Adaptor | 08/30/2024 |
| K241476 | Epic Medical Pte. Ltd. | ToxiSealÖ Vial Adaptor with External Flip Balloon | 06/21/2024 |
| K243976 | Epic Medical Pte. Ltd. | ZeroClearÖ Bag Access (423100) | 01/22/2025 |
| K132899 | EQUASHIELD MEDICAL LTD | EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) | 05/13/2014 |
| K150219 | EQUASHIELD MEDICAL LTD | Equashield Closed System drug Transfer Device (CSTD) | 11/05/2015 |
| K170706 | Equashield Medical Ltd. | Equashield Closed System drug Transfer Device (CSTD) | 07/03/2017 |
| K221513 | EQUASHIELD Medical Ltd. | Equashield Closed System Transfer Device | 02/17/2023 |
| K190157 | ICU Medical | Diana ChemoClave Transfer Set | 10/23/2019 |
| K131549 | ICU MEDICAL INC | CHEMOLOCK, CHEMOLOCK PORT | 07/26/2013 |
| K170110 | ICU MEDICAL INC | Diana Medication Transfer Set | 08/10/2018 |
| K173477 | ICU Medical, Inc. | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | 08/31/2018 |
| K180574 | J & J Solutions, Inc. d/b/a/ Corvida Medical | Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor | 08/17/2018 |
| K150486 | J & J Solutions, Inc. d/b/a/Corvida Medical | Halo | 07/24/2015 |
| K172499 | JMS North America Corporation | NEOSHIELD | 06/01/2018 |
| K201460 | Shinva Ande Healthcare Apparatus Co., Ltd. | Closed System Transfer Device | 11/23/2022 |
| K192866 | Simplivia Healthcare Ltd. | Chemfort CSTD | 05/07/2020 |
| K231286 | Simplivia Healthcare LTD. | Chemfort« Catheter Adaptor | 08/02/2023 |
| K210707 | Simplivia Healthcare LTD. | OnGuard2 Chemfort Closed Administration (CADM) | 09/23/2021 |
| K201142 | Simplivia Healthcare Ltd. | TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set | 02/25/2021 |
| K170680 | Teva Medical Ltd., Migada Plant | TEVADAPTOR Closed Drug Reconstitution and Transfer System | 05/16/2017 |
| K180489 | Teva Medical Ltd., Migada Plant | TEVADAPTOR Closed Drug Reconstitution and Transfer System | 09/21/2018 |
| K141448 | TEVA MEDICAL LTD., MIGADA PLANT | TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | 01/23/2015 |
| K201422 | Yukon Medical, LLC | Arisure Closed System Drug Transfer Device (CSTD) | 03/02/2021 |
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