DORA Tubing Sets for Hemodialysis— 510(k) K161582

Substantially Equivalent

Bain Medical Equipment (Guangzhou) Co., Ltd.

FDA 510(k) clearance K161582 for DORA Tubing Sets for Hemodialysis, Substantially Equivalent on 2017-06-16. Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd..

Clearance details

Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 2016-06-08
Decision date: 2017-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.