# K133465: Consure Stool Management System

- Pathway: 510(k) (Traditional)
- Applicant: Consure Medical Pvt, Ltd.
- Decided: Jun 26, 2014 after 226 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: 5 generations back to K813526 (1982). 8 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K102391: Bard Dignishield Stool Management System, C.R. Bard, Inc. (2010) Summary page 1.

## Most influential descendants
- 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

## Indications for use
Consure 120 SMS is indicated for fecal management by diverting and collecting liquid or semi-formed stool to minimize skin contact in bedridden patients.

Source page: https://510kreport.com/device/K133465
Methodology: https://510kreport.com/methodology