510(k) Report

Devices descending from K160881

10 later devices reach Tablo Console through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200741Tablo Hemodialysis SystemOutset Medical, Inc.202071
+1K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.201922
+2K211370Tablo Hemodialysis SystemOutset Medical, Inc.202261
+2K210782Tablo CartridgeOutset Medical, Inc.20211—
+3K233798Moda-flx Hemodialysis System and CartridgeDiality, Inc.20240—
+3K233557HemoCare Hemodialysis SystemDeka Research and Development20240—
+3K223248Tablo® Hemodialysis SystemOutset Medical, Inc.20234—
+4K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerOutset Medical, Inc.202401
+4K233335Tablo® Hemodialysis SystemOutset Medical, Inc.20231Class I
+5K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.20260—