ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System Class II
FDA product code ONB covers "Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System", a Class II medical device regulated under 21 CFR 880.5440. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |