# K063118: Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Feb 13, 2007 after 125 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: 1 generation back to K915841 (1993). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915841: Bard Gauderer Universal Percutaneous Endoscopic, C.R. Bard, Inc. (1993) Summary page 1.

## Most influential descendants
- K092049: Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit (2009), 2 descendants of its own
- K102572: Iyunni 3ID Suprapubic Cystostomy Tube Kit (2010), 0 descendants of its own
- K100173: Iyunni 3ID Tri-Funnel Feeding Tube Kit (2010), 0 descendants of its own

## Indications for use
For initial percutaneous placement of a gastrostomy feeding and/or decompression device into a stoma created by tissue dilation. Also for percutaneous replacement of a gastrostomy feeding and/or decompression device into an established stoma site.

Source page: https://510kreport.com/device/K063118
Methodology: https://510kreport.com/methodology