510(k) Report

Devices descending from K122347

5 later devices reach Elisio-H and Elisio-M Hemodialyzers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131935Elisio-H Hemodialyzer, Elisio-M HemodialyzerNipro Medical Corporation20133—
+1K131381Elisio-H HemodialyzerNipro Medical Corporation20132—
+2K260533Elisio™-HNipro Medical Corporation20260—
+2K160444FB-U HemodialyzerNipro Medical Corporation20170—
+2K140191Elisio-H HemodialyzerNipro Medical Corporation20141—