K250357 is an FDA 510(k) clearance for the RemunityPRO™ Pump for Remodulin® (treprostinil) Injection. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on March 11, 2025, 32 days after receiving the submission on February 7, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K250357 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2025 |
| Decision Date | March 11, 2025 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRN - Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |