Clearance Summary
RemunityPRO Pump for Remodulin® (treprostinil) Injection received FDA 510(k) clearance under submission number K250357, sponsored by Deka Research & Development Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2025-03-11.
- Submission: K250357
- Applicant / Sponsor: Deka Research & Development Corp.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2025-03-11
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.