510(k) Report

Devices descending from K190182

7 later devices reach Unity Subcutaneous Delivery System for Remodulin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp.20252—
+1K191313Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development20203—
+2K250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp.20251—
+2K243354Remunity SystemDeka Research & Development Corp.20240—
+2K202690Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development20201—
+3K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp20260—
+3K240256Remunity SystemDeka Research and Development20240—