# K083153: Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Feb 4, 2009 after 103 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 K813526 (1982). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023344: Indwelling Fecal Management System-Non-Sterile, Bowel Management Systems, LLC (2002) Summary page 1.
- K012113: Indwelling Fecal Management System, Bowel Management Systems, LLC (2002) Summary page 1.

## Most influential descendants
- K102391: Bard Dignishield Stool Management System (2010), 4 descendants of its own
- K133465: Consure Stool Management System (2014), 2 descendants of its own
- K100273: Instaflo Bowel Catheter System Kit (2010), 2 descendants of its own
- K153506: Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit (2016), 1 descendant of its own
- K123804: Instaflo Bowel Catheter System Kit (2013), 1 descendant of its own

## Indications for use
The ActiFlo Indwelling Bowel Catheter System is intended for diversion of fecal matter to minimize external contact with the patient's skin, to facilitate the collection of fecal matter for patients requiring stool management, to provide access for colonic irrigation and to administer enema/medications.

Source page: https://510kreport.com/device/K083153
Methodology: https://510kreport.com/methodology