# K152938: DBB-06 Hemodialysis Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Nikkiso CO., LTD.
- Decided: Mar 18, 2016 after 165 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: 5 generations back to K921456 (1994). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 12 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091978: DBB-06 Hemodialysis Delivery System, Nikkiso CO., LTD. (2010) Summary page 4.
- K083460: Dialog with Adimea Option, B. Braun Avitum AG (2010) Summary page 4.

## Most influential descendants
- 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/K152938
Methodology: https://510kreport.com/methodology