Cleared Traditional

K161582 - DORA Tubing Sets for Hemodialysis

K161582 is an FDA 510(k) clearance for DORA Tubing Sets for Hemodialysis, manufactured by Bain Medical Equipment (Guangzhou) Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K161582 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
373d
Days
Class 2
Risk

K161582 is an FDA 510(k) clearance for the DORA Tubing Sets for Hemodialysis. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Bain Medical Equipment (Guangzhou) Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on June 16, 2017 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bain Medical Equipment (Guangzhou) Co., Ltd. devices

FDA 510(k) Submission Details - K161582

510(k) Number K161582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2016
Decision Date June 16, 2017
Days to Decision 373 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
243d slower than avg
Panel avg: 130d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJK Device Classification - Class 2, Special Controls

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 47
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K161582.
SANSIN Tubing Sets for Hemodialysis
K202796 · Jiangxi Sanxin Medtec Co., Ltd. · Sep 2021
NovaLine Tubing Sets for Hemodialysis
K201866 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Mar 2021
Dimesol Tubing Sets for Hemodialysis
K171952 · Dimesol, Inc. · Mar 2018
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
K112628 · Nipro Medical Corporation · Sep 2012
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · Nxstage Medical, Inc. · Feb 2009
BLOOD TUBING SETS (STERILE FLUID PATH)
K080807 · Nxstage Medical, Inc. · Jul 2008