# K073598: Bard Dignicare Stool Management System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 13, 2008 after 175 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). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032734: Convatec Fecal Management System, Convatec, A Bristol-Myers Squibb Co. (2004) Summary page 1.
- K023344: Indwelling Fecal Management System-Non-Sterile, 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
- K153506: Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit (2016), 1 descendant of its own
- K212444: Qora Stool Management Kit (2021), 0 descendants of its own
- K133251: Bard Dignishield Stool Management System (2014), 0 descendants of its own

## Indications for use
The BardoDigniCareStool Management System is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients. Adult Use Only

Source page: https://510kreport.com/device/K073598
Methodology: https://510kreport.com/methodology