# K061519: Modification to DBB-05 Hemodialysis Delivery System

- Pathway: 510(k) (Special)
- Applicant: Nikkiso CO., LTD.
- Decided: Sep 28, 2007 after 484 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K921456 (1994). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023509: DBB-05 Hemodialysis Delivery System, Davita Clinical Research (Trri) (2003) Summary page 2.

## Most influential descendants
- K091978: DBB-06 Hemodialysis Delivery System (2010), 2 descendants of its own
- K152938: DBB-06 Hemodialysis Delivery System (2016), 1 descendant of its own
- K242155: DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (2025), 0 descendants of its own

## Indications for use
The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.

Source page: https://510kreport.com/device/K061519
Methodology: https://510kreport.com/methodology