510(k) Report

Devices descending from K211370

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+1K223248Tablo® Hemodialysis SystemOutset Medical, Inc.20234—
+2K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+2K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc.202401
+2K233335Tablo® Hemodialysis SystemOutset Medical, Inc.20231Class I
+3K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.20260—