Cleared Traditional

K100173 - IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT

K100173 is an FDA 510(k) clearance for IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT, manufactured by Sainath Intellectual Properties, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K100173 · Sainath Intellectual Properties, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
85d
Days
Class 2
Risk

K100173 is an FDA 510(k) clearance for the IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Sainath Intellectual Properties, LLC (Largo, US). The FDA issued a Cleared decision on April 16, 2010 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sainath Intellectual Properties, LLC devices

FDA 510(k) Submission Details - K100173

510(k) Number K100173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 21, 2010
Decision Date April 16, 2010
Days to Decision 85 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
46d faster than avg
Panel avg: 131d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 498
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