DBB-06 Hemodialysis Delivery System— 510(k) K152938

Substantially Equivalent

NIKKISO CO., LTD.

FDA 510(k) clearance K152938 for DBB-06 Hemodialysis Delivery System, Substantially Equivalent on 2016-03-18. Applicant: NIKKISO CO., LTD..

Clearance details

Applicant: NIKKISO CO., LTD.
Product code: Code KDI
Advisory panel: Gastroenterology, Urology
Date received: 2015-10-05
Decision date: 2016-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shibuya-Ku, 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.