# K242155: DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)

- Pathway: 510(k) (Traditional)
- Applicant: Nikkiso CO., LTD.
- Decided: May 15, 2025 after 296 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: 12 generations back to K921456 (1994). 28 ancestors in all.
No later device cites it as a predicate yet.
3 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152938: DBB-06 Hemodialysis Delivery System, Nikkiso CO., LTD. (2016) Summary page 6.
- K231125: 2008T BlueStar Hemodialysis Machine, Fresenius Medical Care Renal Therapies Group, LLC (2023) Summary page 6.

## Indications for use
The DBB-06 PRO 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 PRO Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.

Source page: https://510kreport.com/device/K242155
Methodology: https://510kreport.com/methodology