# K191313: Unity Subcutaneous Infusion System for Remodulin

- Pathway: 510(k) (Traditional)
- Applicant: DEKA Research & Development
- Decided: Feb 21, 2020 after 282 days
- Product code: QJY (Infusion Pump, Drug Specific, Pharmacy-Filled)
- 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: 2 generations back to K051568 (2005). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190182: Unity Subcutaneous Delivery System for Remodulin, DEKA Research & Development (2019) Summary page 4.

## Most influential descendants
- K202690: Remunity Pump for Remodulin (treprostinil) Injection (2020), 1 descendant of its own
- K243354: Remunity System (2024), 0 descendants of its own
- K240256: Remunity System (2024), 0 descendants of its own

## Indications for use
The Unity Subcutaneous Infusion System (the Unity System) is intended for continuous subcutaneous delivery of Remodulin® (treprostinil) Injection for use in adults (greater than 22 years of age).

Source page: https://510kreport.com/device/K191313
Methodology: https://510kreport.com/methodology