Cleared Traditional

K251442 - TIANYI Extracorporeal Blood Tubing Set ...

K251442 is an FDA 510(k) clearance for TIANYI Extracorporeal Blood Tubing Set ..., manufactured by Ningbo Tianyi Medical Appliance Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K251442 · Ningbo Tianyi Medical Appliance Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
146d
Days
Class 2
Risk

K251442 is an FDA 510(k) clearance for the TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1). Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Ningbo Tianyi Medical Appliance Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on October 2, 2025 after a review of 146 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Ningbo Tianyi Medical Appliance Co., Ltd. devices

FDA 510(k) Submission Details - K251442

510(k) Number K251442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2025
Decision Date October 02, 2025
Days to Decision 146 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
16d slower than avg
Panel avg: 130d · This submission: 146d
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 Consultant

Suzhou Device Innovation Medical Consulting Co., Ltd.
Mike Gu

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 46
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K251442.
NovaLine Tubing Set for Hemodialysis (BL 124)
K252423 · Bain Medical Equipment (Guangzhou) Co., Ltd. · May 2026
VITAL Tubing Sets for Hemodialysis
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Moda-flx Hemodialysis System™ Cartridge (102121-001 )
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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