Cleared Traditional

K202796 - SANSIN 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.

K202796 · Jiangxi Sanxin Medtec Co., Ltd. · Gastroenterology & Urology device
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Sep 2021
Decision
348d
Days
Class 2
Risk

K202796 is an FDA 510(k) clearance for the SANSIN Tubing Sets for Hemodialysis. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Jiangxi Sanxin Medtec Co., Ltd. (Nanchang, CN). The FDA issued a Cleared decision on September 6, 2021 after a review of 348 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 Jiangxi Sanxin Medtec Co., Ltd. devices

Submission Details

510(k) Number K202796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2020
Decision Date September 06, 2021
Days to Decision 348 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 130d · This submission: 348d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K202796.
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
NovaLine Tubing Sets for Hemodialysis
K201866 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Mar 2021