# K091978: DBB-06 Hemodialysis Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Nikkiso CO., LTD.
- Decided: Mar 25, 2010 after 267 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K921456 (1994). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 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 1.
- K061519: Modification to DBB-05 Hemodialysis Delivery System, Nikkiso CO., LTD. (2007) Summary page 1.
- K972470: Crit-Line Monitor (Clmiii), In-Line Diagnostics Corp. (1997) Summary page 7.
- K973637: Press-Mate Advantage, Colin Medical Instruments Corp. (1998) Summary page 7.

## Most influential descendants
- 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

## Recalls of this device
- Nov 24, 2021 · Class II · Z-0456-2022: Device lacks premarket approval.

## Indications for use
The DBB-06 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.

Source page: https://510kreport.com/device/K091978
Methodology: https://510kreport.com/methodology