510(k) Report

Devices descending from K050727

5 later devices reach Modification to Nxstage Cartridge Express through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061837Nxstage Cartridge ExpressNxstage Medical, Inc.200641
+2K232803NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)Nxstage Medical, Inc.20240—
+2K183158NxStage Cartridge Express with SpeedswapNxstage Medical, Inc.201901
+2K131050Nxstage 1.6M2 DialyzerNxstage Medical, Inc.20130—
+2K123395Nxstage System One Low Volume Cartridge ExpressNxstage Medical, Inc.20130—