# K190182: Unity Subcutaneous Delivery System for Remodulin

- Pathway: 510(k) (Traditional)
- Applicant: DEKA Research & Development
- Decided: May 6, 2019 after 94 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: 1 generation back to K051568 (2005). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051568: Cadd-MS 3 Ambulatory Infusion Pump, Smiths Medical MD, Inc. (2005) Summary page 4.

## Most influential descendants
- K191313: Unity Subcutaneous Infusion System for Remodulin (2020), 3 descendants of its own
- K241736: Remunity 2.0 Pump for Remodulin (treprostinil) Injection (2025), 2 descendants of its own
- K250357: RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (2025), 1 descendant of its own
- K202690: Remunity Pump for Remodulin (treprostinil) Injection (2020), 1 descendant of its own
- K253703: RemunityPRO+ Pump for Remodulin® (treprostinil) Injection (2026), 0 descendants of its own

## Indications for use
The Unity Subcutaneous Delivery System for Remodulin® (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/K190182
Methodology: https://510kreport.com/methodology