# K133251: Bard Dignishield Stool Management System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: May 9, 2014 after 199 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: 6 generations back to K813526 (1982). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102391: Bard Dignishield Stool Management System, C.R. Bard, Inc. (2010) Summary page 1.
- K073598: Bard Dignicare Stool Management System, C.R. Bard, Inc. (2008) Summary page 1.
- K112342: Flexi-Seal Signal Fecal Management System, Convatec, Inc. (2012) Summary page 1.
- K123804: Instaflo Bowel Catheter System Kit, Hollister, Inc. (2013) Summary page 1.

## Indications for use
The Bard® DigniShield® Stool Management System with odor barrier properties is intended for fecal management by diverting and collecting liquid or semi-liquid stool to minimize skin contact in bedridden patients and to provide access for the administration of medications. Adult use only.

Source page: https://510kreport.com/device/K133251
Methodology: https://510kreport.com/methodology