510(k) K253703
K253703 is an FDA 510(k) premarket notification submitted by Deka R&D Corp for the device "RemunityPRO+ Pump for Remodulin® (treprostinil) Injection". The FDA issued a decision of Substantially Equivalent on Jul 24, 2026. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2026
- Date Received
- Nov 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pump, Infusion
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type
- 510(k)