K241736 is an FDA 510(k) clearance for the Remunity 2.0 Pump for Remodulin (treprostinil) Injection. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by Deka Research and Development Corp. (Manchester, US). The FDA issued a Cleared decision on January 16, 2025, 213 days after receiving the submission on June 17, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K241736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2024 |
| Decision Date | January 16, 2025 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| 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 |