510(k) Report

Devices descending from K051568

10 later devices reach Cadd-MS 3 Ambulatory Infusion Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230718UTC 3mL Medication CartridgeGilero, LLC20230—
+1K201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.20210—
+1K190182Unity Subcutaneous Delivery System for RemodulinDEKA Research & Development20197—
+2K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionDeka Research and Development Corp.20252—
+2K191313Unity Subcutaneous Infusion System for RemodulinDEKA Research & Development20203—
+3K250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionDeka Research & Development Corp.20251—
+3K243354Remunity SystemDeka Research & Development Corp.20240—
+3K202690Remunity Pump for Remodulin (treprostinil) InjectionDeka Research and Development20201—
+4K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp20260—
+4K240256Remunity SystemDeka Research and Development20240—