K250459 is an FDA 510(k) clearance for the DMRX 100ml Empty Container Solution. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).
Submitted by Technoflex Sas. (Bidart, FR). The FDA issued a Cleared decision on April 18, 2025, 59 days after receiving the submission on February 18, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.
| 510(k) Number | K250459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2025 |
| Decision Date | April 18, 2025 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KPE - Container, I.v. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5025 |