510(k) Report

Devices descending from K810127

6 later devices reach Gambro Bicarbonate Module, BCM-10 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043436Nxstage Dialysate Preparation Module, Model NX0269Nxstage Medical, Inc.20055—
+2K081043Leak Detection Sensor and Tray Accessory KitNxstage Medical, Inc.20080—
+2K060296Nxstage Dialysate Preparation ModuleNxstage Medical, Inc.20063—
+3K080919Nxstage Pureflow SLNxstage Medical, Inc.200821
+4K111174Nxstage Pureflow SLNxstage Medical, Inc.201119
+5K140571Nxstage Pureflow SLNxstage Medical, Inc.201409