# K100173: Iyunni 3ID Tri-Funnel Feeding Tube Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sainath Intellectual Properties, LLC
- Decided: Apr 16, 2010 after 85 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915841 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092049: Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit, Sainath Intellectual Properties, LLC (2009) Summary page 1.
- K063118: Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube, C.R. Bard, Inc. (2007) Summary page 1.
- K080253: Kimberly-Clark Introducer Kits, Kimberly-Clark Corp. (2008) Summary page 1.

## Indications for use
The IYUNNI 31D Tri-Funnel Feeding Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication using a Percutaneous Endoscopic Gastrostomy procedure. The gastrostomy tube may also be used for gastric decompression.

Source page: https://510kreport.com/device/K100173
Methodology: https://510kreport.com/methodology