# K023344: Indwelling Fecal Management System-Non-Sterile

- Pathway: 510(k) (Special)
- Applicant: Bowel Management Systems, LLC
- Decided: Nov 6, 2002 after 30 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: 2 generations back to K813526 (1982). 3 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012113: Indwelling Fecal Management System, Bowel Management Systems, LLC (2002) Summary page 3.
- K841289: Rectal Irrigation Tube, Hdc Corp. (1984) Summary page 3.
- K813526: Fecal Sanitary Tube, Leon'S Fecal Sanitary Tub Mfg. (1982) Summary page 3.
- (no number) Virden Rectal Catheter: named in the summary without a submission number

## Most influential descendants
- K083153: Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007 (2009), 7 descendants of its own
- K083770: Coloplast Peristeen Anal Irrigation (Pai) System (2009), 5 descendants of its own
- K073598: Bard Dignicare Stool Management System (2008), 5 descendants of its own
- K103254: Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter, System Strap, Irrigation Tube (2011), 4 descendants of its own
- K102391: Bard Dignishield Stool Management System (2010), 4 descendants of its own

## Indications for use
Diversion of fecal mater 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 enemadmedication.

Source page: https://510kreport.com/device/K023344
Methodology: https://510kreport.com/methodology