ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System Class II
Classification Details
- Product Code
- ONB
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251722 | epic medical pte. | ProSeal Transfer Injector (421120, 421130, 421140) | December 5, 2025 |
| K253033 | simplivia healthcare | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | October 21, 2025 |
| K250059 | becton, dickinson and | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | September 12, 2025 |
| K251411 | simplivia healthcare | Chemfort Female Luer Lock Adaptor | August 5, 2025 |
| K251340 | epic medical pte. | ProSeal Bag Spike with Additive Port (423370ST, 423370) | May 29, 2025 |
| K243976 | epic medical pte. | ZeroClear Bag Access (423100) | January 22, 2025 |
| K240517 | epic medical pte. | ProSeal Vented Universal Vial Adaptor | December 26, 2024 |
| K241988 | epic medical pte. | ProSeal Closed System Bag Access | October 23, 2024 |
| K241735 | epic medical pte. | ProSeal In Line Pump Set (423850) | October 10, 2024 |
| K241823 | epic medical pte. | ToxiSeal Vial Adaptor | August 30, 2024 |
| K241476 | epic medical pte. | ToxiSeal Vial Adaptor with External Flip Balloon | June 21, 2024 |
| K240433 | epic medical pte. | ProSeal Injection Site Extended Male Luer Lock (422140) | May 21, 2024 |
| K240171 | epic medical pte. | ProSeal Injector Plus (Model no. 421050) | March 28, 2024 |
| K222929 | epic medical pte. | ToxiSeal Vial Adapter with External Balloon | January 11, 2024 |
| K231286 | simplivia healthcare | Chemfort® Catheter Adaptor | August 2, 2023 |
| K223076 | care fusion | BD Texium Closed Male Luer | March 24, 2023 |
| K221513 | equashield medical | Equashield Closed System Transfer Device | February 17, 2023 |
| K201460 | shinva ande healthcare apparatus co | Closed System Transfer Device | November 23, 2022 |
| K210707 | simplivia healthcare | OnGuard2 Chemfort Closed Administration (CADM) | September 23, 2021 |
| K201422 | yukon medical | Arisure Closed System Drug Transfer Device (CSTD) | March 2, 2021 |