K251340 is an FDA 510(k) clearance for the ProSeal™ Bag Spike with Additive Port (423370ST, 423370). This device is classified as a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II - Special Controls, product code ONB).
Submitted by Epic Medical Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 29, 2025, 29 days after receiving the submission on April 30, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440. Reconstitute And Transfer Antineoplastic And Other Hazardous Drugs In Healthcare Setting Indicated To Reduce Exposure Of Healthcare Personnel To Chemotherapy Agents In Healthcare Setting..
| 510(k) Number | K251340 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2025 |
| Decision Date | May 29, 2025 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | ONB — Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |
| 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. |