Cleared Traditional

NovaLine Tubing Sets for Hemodialysis

K201866 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Gastroenterology & Urology

Mar 2021

Decision

246d

Days

Class 2

Risk

About This 510(k) Submission

K201866 is an FDA 510(k) clearance for the NovaLine Tubing Sets for Hemodialysis, a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II — Special Controls, product code FJK), submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 10, 2021, 246 days after receiving the submission on July 7, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number	K201866 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2020
Decision Date	March 10, 2021
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FJK — Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5820