# K012113: Indwelling Fecal Management System

- Pathway: 510(k) (Traditional)
- Applicant: Bowel Management Systems, LLC
- Decided: May 3, 2002 after 301 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 K813526 (1982). 2 ancestors in all.
26 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841289: Rectal Irrigation Tube, Hdc Corp. (1984) Summary page 1.
- K813526: Fecal Sanitary Tube, Leon'S Fecal Sanitary Tub Mfg. (1982) Summary page 1.
- (no number) Bard Virden Rectal Catheter: named in the summary without a submission number

## Most influential descendants
- K023344: Indwelling Fecal Management System-Non-Sterile (2002), 16 descendants of its own
- K032734: Convatec Fecal Management System (2004), 14 descendants of its own
- K112342: Flexi-Seal Signal Fecal Management System (2012), 8 descendants of its own
- K083153: Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007 (2009), 7 descendants of its own
- K150350: Flexi-Seal Signal Fecal Management System (2015), 6 descendants of its own

## Indications for use
Diversion of fecal matter to minimize external contact with the patient, to facilitate the collection of fecal matter for patients requiring stool management, and to provide access for colonic irrigation to trigger a defecatory response, and administration of enemas/medications.

Source page: https://510kreport.com/device/K012113
Methodology: https://510kreport.com/methodology