# K250357: RemunityPRO™ Pump for Remodulin® (treprostinil) Injection

- Pathway: 510(k) (Special)
- Applicant: Deka Research & Development Corp.
- Decided: Mar 11, 2025 after 32 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K051568 (2005). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241736: Remunity 2.0 Pump for Remodulin (treprostinil) Injection, Deka Research and Development Corp. (2025) Summary page 5.

## Most influential descendants
- K253703: RemunityPRO+ Pump for Remodulin® (treprostinil) Injection (2026), 0 descendants of its own

## Indications for use
The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (the RemunityPRO System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in patients, ages 17 and older.

Source page: https://510kreport.com/device/K250357
Methodology: https://510kreport.com/methodology