Product code ONB
- Device name
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5440
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251722 | ProSeal™ Transfer Injector (421120, 421130, 421140) | Epic Medical Pte. , Ltd. | 2025-12-05 |
| K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. | 2025-10-21 |
| K250059 | BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) | Becton, Dickinson and Company | 2025-09-12 |
| K251411 | Chemfort Female Luer Lock Adaptor | Simplivia Healthcare , Ltd. | 2025-08-05 |
| K251340 | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte. , Ltd. | 2025-05-29 |
| K243976 | ZeroClear™ Bag Access (423100) | Epic Medical Pte. , Ltd. | 2025-01-22 |
| K240517 | ProSeal™ Vented Universal Vial Adaptor | Epic Medical Pte. , Ltd. | 2024-12-26 |
| K241988 | ProSeal™ Closed System Bag Access | Epic Medical Pte. , Ltd. | 2024-10-23 |
| K241735 | ProSeal™ In Line Pump Set (423850) | Epic Medical Pte. , Ltd. | 2024-10-10 |
| K241823 | ToxiSeal™ Vial Adaptor | Epic Medical Pte. , Ltd. | 2024-08-30 |
| K241476 | ToxiSeal™ Vial Adaptor with External Flip Balloon | Epic Medical Pte. , Ltd. | 2024-06-21 |
| K240433 | ProSeal™ Injection Site Extended Male Luer Lock (422140) | Epic Medical Pte. , Ltd. | 2024-05-21 |
| K240171 | ProSeal™ Injector Plus (Model no. 421050) | Epic Medical Pte. , Ltd. | 2024-03-28 |
| K222929 | ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte. , Ltd. | 2024-01-11 |
| K231286 | Chemfort® Catheter Adaptor | Simplivia Healthcare , Ltd. | 2023-08-02 |
| K223076 | BD Texium™ Closed Male Luer | Care Fusion | 2023-03-24 |
| K221513 | Equashield Closed System Transfer Device | Equashield Medical , Ltd. | 2023-02-17 |
| K201460 | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-11-23 |
| K210707 | OnGuard2 Chemfort Closed Administration (CADM) | Simplivia Healthcare , Ltd. | 2021-09-23 |
| K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | 2021-03-02 |
| K201142 | 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 | Simplivia Healthcare , Ltd. | 2021-02-25 |
| K201099 | BD PhaSeal Optima Closed System Drug Transfer Device | Becton, Dickinson and Company | 2020-08-12 |
| K192075 | ProSeal™ Closed System drug Transfer Device (CSTD) | Epic Medical Pte. , Ltd. | 2020-08-07 |
| K192866 | Chemfort CSTD | Simplivia Healthcare , Ltd. | 2020-05-07 |
| K190157 | Diana ChemoClave Transfer Set | Icu Medical | 2019-10-23 |
| K181221 | BD PhaSeal Optima Closed System Transfer Device | Becton, Dickinson and Company | 2018-11-30 |
| K180489 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2018-09-21 |
| K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | Icu Medical, Inc. | 2018-08-31 |
| K180574 | 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 | J & J Solutions, Inc. D/B/A/ Corvida Medical | 2018-08-17 |
| K170110 | Diana Medication Transfer Set | Icu Medical, Inc. | 2018-08-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 18859299133857 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2026-03-11 |
| 18859299131051 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2026-03-11 |
| 18859299131013 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2026-03-11 |
| 18859299130719 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2025-09-11 |
| 18859299124152 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2025-09-11 |
| 18859299124145 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2025-09-11 |
| 18859299124138 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2025-09-11 |
| 18859299124121 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2025-09-11 |
| 18859299124114 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2025-09-11 |
| 18859299119950 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2025-09-11 |
| 18859299130696 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2025-09-11 |
| 18859299130702 | ProSeal CSTD | EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED | 2025-09-11 |
| 10885403470127 | MaxZero | BD Switzerland Sàrl | 2023-07-27 |
| 27290115921148 | OnGuard Luer Lock Adaptor | SIMPLIVIA HEALTHCARE LTD | 2022-10-03 |
| 27290115921636 | OnGuard®2 CSTD Syringe Adaptor | SIMPLIVIA HEALTHCARE LTD | 2020-07-12 |
| 27290115921438 | OnGuard®2 CSTD Bag Adaptor SP | SIMPLIVIA HEALTHCARE LTD | 2020-07-12 |
| 27290115921605 | OnGuard®2 CSTD Luer Lock Adaptor | SIMPLIVIA HEALTHCARE LTD | 2020-07-12 |
| 27290115921629 | OnGuard®2 CSTD 28mm Vial Adaptor | SIMPLIVIA HEALTHCARE LTD | 2020-07-12 |
| 27290115921612 | OnGuard®2 CSTD 20mm Vial Adaptor and 13mm Convertor | SIMPLIVIA HEALTHCARE LTD | 2020-07-09 |
| 10858743005069 | Halo | J & J SOLUTIONS, INC. | 2016-09-23 |
| 10858743005052 | Halo | J & J SOLUTIONS, INC. | 2016-09-23 |
| 10858743005045 | Halo | J & J SOLUTIONS, INC. | 2016-09-23 |
| 10858743005038 | Halo | J & J SOLUTIONS, INC. | 2016-09-23 |
| 10858743005021 | Halo | J & J SOLUTIONS, INC. | 2016-09-23 |
| 10858743005014 | Halo | J & J SOLUTIONS, INC. | 2016-09-23 |
| 10858743005007 | Halo | J & J SOLUTIONS, INC. | 2016-09-23 |
| 17298119121192 | TEVADAPTOR® 28mm Vial Adaptor | TEVA PHARMACEUTICAL INDUSTRIES LIMITED | 2016-09-15 |
| 17298119121185 | TEVADAPTOR® Syringe Adaptor | TEVA PHARMACEUTICAL INDUSTRIES LIMITED | 2016-09-15 |
| 17298119121147 | TEVADAPTOR® Luer Lock Adaptor | TEVA PHARMACEUTICAL INDUSTRIES LIMITED | 2016-09-15 |
| 17298119121116 | TEVADAPTOR® Vial Adaptor | TEVA PHARMACEUTICAL INDUSTRIES LIMITED | 2016-09-15 |