Clearance Summary
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection received FDA 510(k) clearance under submission number K253703, sponsored by Deka R&D Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2026-07-24.
- Submission: K253703
- Applicant / Sponsor: Deka R&D Corp
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2026-07-24
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.