# K102391: Bard Dignishield Stool Management System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 22, 2010 after 121 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: 4 generations back to K813526 (1982). 7 ancestors in all.
4 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)
- K073598: Bard Dignicare Stool Management System, C.R. Bard, Inc. (2008) Summary page 1.
- K083153: Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007, Hollister, Inc. (2009) Summary page 1.

## Most influential descendants
- 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 BARD® DigniShield™ Stool 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/K102391
Methodology: https://510kreport.com/methodology