510(k) Report

Devices descending from K223248

4 later devices reach Tablo® Hemodialysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+1K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc.202401
+1K233335Tablo® Hemodialysis SystemOutset Medical, Inc.20231Class I
+2K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.20260—