# K123804: Instaflo Bowel Catheter System Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Apr 17, 2013 after 128 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: 5 generations back to K813526 (1982). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100273: Instaflo Bowel Catheter System Kit, Hollister, Inc. (2010) Summary page 1.

## Most influential descendants
- K133251: Bard Dignishield Stool Management System (2014), 0 descendants of its own

## Indications for use
A bowel catheter system kit with odor barrier properties for diversion of liquid or semi-liquid stool to facilitate the collection of fecal matter in patients with little or no bowel control.

Source page: https://510kreport.com/device/K123804
Methodology: https://510kreport.com/methodology