510(k) Report

Devices descending from K093120

6 later devices reach Xenium XPM 110, Xenium XPM 130, Models M25649A, M25650A, Xenium XPM 150… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122347Elisio-H and Elisio-M HemodialyzersNipro Medical Corporation20135—
+2K131935Elisio-H Hemodialyzer, Elisio-M HemodialyzerNipro Medical Corporation20133—
+2K131381Elisio-H HemodialyzerNipro Medical Corporation20132—
+3K260533Elisio™-HNipro Medical Corporation20260—
+3K160444FB-U HemodialyzerNipro Medical Corporation20170—
+3K140191Elisio-H HemodialyzerNipro Medical Corporation20141—