Cleared Traditional

K161582 - DORA Tubing Sets for Hemodialysis (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161582 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Gastroenterology & Urology device
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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

Submission Details

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.

Device Classification

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 75
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K161582.
VITAL Tubing Sets for Hemodialysis
K251341 · Vital Healthcare Sdn. Bhd. · Jan 2026
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
K251442 · Ningbo Tianyi Medical Appliance Co., Ltd. · Oct 2025
Moda-flx Hemodialysis System™ Cartridge (102121-001 )
K243607 · Diality, Inc. · Dec 2024
CombiSet Hemodialysis Blood Tubing Set
K213992 · Fresenius Medical Care Renal Therapies Group, LLC · May 2023
Tablo Cartridge
K210782 · Outset Medical, Inc. · Nov 2021
SANSIN Tubing Sets for Hemodialysis
K202796 · Jiangxi Sanxin Medtec Co., Ltd. · Sep 2021