Name: Predicase
Price: 199 USD

K-number	K251442
Device name	TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
Applicant	Ningbo Tianyi Medical Appliance Co., Ltd.
Product code	FJK
Device class	Class II
Decision date	Oct 2, 2025
Decision	Substantially Equivalent
Regulation	876.5820

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

Everything you need for a 510(k) submission. Nothing you don't.