Panels › General Hospital › Product code ONB · Class 2
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Regulation 880.5440
1510(k)s in 12 months (41 all time)
3recalls in 12 months (73 all time)
69recalls that name a 510(k)
Top companies in ONB
| Company | 510(k)s | Recalls |
|---|---|---|
| Icu Medical | 4 | 68 |
| Epic Medical Pte. , Ltd. | 12 | 0 |
| Simplivia Healthcare , Ltd. | 6 | 1 |
| Becton, Dickinson and Company | 4 | 0 |
| Equashield Medical , Ltd. | 4 | 0 |
| Becton, Dickinson & CO | 2 | 1 |
| Teva Medical Ltd., Migada Plant | 3 | 0 |
| J & J Solutions, Inc. D/B/A/ Corvida Medical | 2 | 0 |
| B. Braun Medical, Inc. | 0 | 1 |
| BD SWITZERLAND SARL | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2025 | K251722 | ProSeal Transfer Injector (421120, 421130, 421140) Epic Medical Pte. , Ltd., SG | ONB |
| Oct 21, 2025 | K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor Simplivia Healthcare , Ltd., IL | ONB |
| Sep 12, 2025 | K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) Becton, Dickinson and Company | ONB |
| Aug 5, 2025 | K251411 | Chemfort Female Luer Lock Adaptor Simplivia Healthcare , Ltd., IL | ONB |
| May 29, 2025 | K251340 | ProSeal Bag Spike with Additive Port (423370ST, 423370) Epic Medical Pte. , Ltd., SG | ONB |
| Jan 22, 2025 | K243976 | ZeroClear Bag Access (423100) Epic Medical Pte. , Ltd., SG | ONB |
| Dec 26, 2024 | K240517 | ProSeal Vented Universal Vial Adaptor Epic Medical Pte. , Ltd., SG | ONB |
| Oct 23, 2024 | K241988 | ProSeal Closed System Bag Access Epic Medical Pte. , Ltd., SG | ONB |
| Oct 10, 2024 | K241735 | ProSeal In Line Pump Set (423850) Epic Medical Pte. , Ltd., SG | ONB |
| Aug 30, 2024 | K241823 | ToxiSeal Vial Adaptor Epic Medical Pte. , Ltd., SG | ONB |
| Jun 21, 2024 | K241476 | ToxiSeal Vial Adaptor with External Flip Balloon Epic Medical Pte. , Ltd., SG | ONB |
| May 21, 2024 | K240433 | ProSeal Injection Site Extended Male Luer Lock (422140) Epic Medical Pte. , Ltd., SG | ONB |
| Mar 28, 2024 | K240171 | ProSeal Injector Plus (Model no. 421050) Epic Medical Pte. , Ltd., SG | ONB |
| Jan 11, 2024 | K222929 | ToxiSeal Vial Adapter with External Balloon Epic Medical Pte. , Ltd., SG | ONB |
| Aug 2, 2023 | K231286 | Chemfort® Catheter Adaptor Simplivia Healthcare , Ltd., IL | ONB |
| Mar 24, 2023 | K223076 | BD Texium Closed Male Luer Care Fusion | ONB |
| Feb 17, 2023 | K221513 | Equashield Closed System Transfer Device Equashield Medical , Ltd., IL | ONB |
| Nov 23, 2022 | K201460 | Closed System Transfer Device Shinva Ande Healthcare Apparatus Co., Ltd., CN | ONB |
| Sep 23, 2021 | K210707 | OnGuard2 Chemfort Closed Administration (CADM) Simplivia Healthcare , Ltd., IL | ONB |
| Mar 2, 2021 | K201422 | Arisure Closed System Drug Transfer Device (CSTD) Yukon Medical, LLC | ONB |
| Feb 25, 2021 | K201142 | TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTO Simplivia Healthcare , Ltd., IL | ONB |
| Aug 12, 2020 | K201099 | BD PhaSeal Optima Closed System Drug Transfer Device Becton, Dickinson and Company | ONB |
| Aug 7, 2020 | K192075 | ProSeal Closed System drug Transfer Device (CSTD) Epic Medical Pte. , Ltd., SG | ONB |
| May 7, 2020 | K192866 | Chemfort CSTD Simplivia Healthcare , Ltd., IL | ONB |
| Oct 23, 2019 | K190157 | Diana ChemoClave Transfer Set Icu Medical | ONB |
| Nov 30, 2018 | K181221 | BD PhaSeal Optima Closed System Transfer Device Becton, Dickinson and Company | ONB |
| Sep 21, 2018 | K180489 | TEVADAPTOR Closed Drug Reconstitution and Transfer System Teva Medical Ltd., Migada Plant, IL | ONB |
| Aug 31, 2018 | K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System Icu Medical, Inc. | ONB |
| Aug 17, 2018 | K180574 | Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Clo J & J Solutions, Inc. D/B/A/ Corvida Medical | ONB |
| Aug 10, 2018 | K170110 | Diana Medication Transfer Set Icu Medical, Inc. | ONB |
| Jun 1, 2018 | K172499 | NEOSHIELD JMS North America Corporation | ONB |
| Jul 3, 2017 | K170706 | Equashield Closed System drug Transfer Device (CSTD) Equashield Medical , Ltd., IL | ONB |
| May 16, 2017 | K170680 | TEVADAPTOR Closed Drug Reconstitution and Transfer System Teva Medical Ltd., Migada Plant, IL | ONB |
| Nov 5, 2015 | K150219 | Equashield Closed System drug Transfer Device (CSTD) Equashield Medical , Ltd., IL | ONB |
| Jul 24, 2015 | K150486 | Halo J & J Solutions, Inc. D/B/A/ Corvida Medical | ONB |
| Jan 23, 2015 | K141448 | TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM Teva Medical Ltd., Migada Plant, IT | ONB |
| May 14, 2014 | K140591 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR Becton, Dickinson & CO | ONB |
| May 13, 2014 | K132899 | EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) Equashield Medical , Ltd. | ONB |
| Jul 26, 2013 | K131549 | CHEMOLOCK, CHEMOLOCK PORT Icu Medical, Inc. | ONB |
| Feb 27, 2013 | K130197 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 Becton, Dickinson and Company | ONB |
| Jan 9, 2013 | K123213 | BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE Becton, Dickinson & CO | ONB |
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