K210707 is an FDA 510(k) clearance for the OnGuard2 Chemfort Closed Administration (CADM). This device is classified as a Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (Class II - Special Controls, product code ONB).
Submitted by Simplivia Healthcare , Ltd. (Kiryat Shmona, IL). The FDA issued a Cleared decision on September 23, 2021, 197 days after receiving the submission on March 10, 2021.
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 | K210707 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2021 |
| Decision Date | September 23, 2021 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| 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. |