510(k) Report

Devices descending from K061519

3 later devices reach Modification to DBB-05 Hemodialysis Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091978DBB-06 Hemodialysis Delivery SystemNikkiso CO., LTD.201021
+2K152938DBB-06 Hemodialysis Delivery SystemNikkiso CO., LTD.201611
+3K242155DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)Nikkiso CO., LTD.20250—