DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)— 510(k) K242155

Substantially Equivalent

NIKKISO CO., LTD.

FDA 510(k) clearance K242155 for DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO), Substantially Equivalent on 2025-05-15. Applicant: NIKKISO CO., LTD..

Clearance details

Applicant: NIKKISO CO., LTD.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2024-07-23
Decision date: 2025-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code KDI

product code KDI

Death: 352
Injury: 1,474
Malfunction: 12,534
Other: 4
Total: 14,364

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.