# K112342: Flexi-Seal Signal Fecal Management System

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, Inc.
- Decided: Apr 26, 2012 after 255 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). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 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.
- K012113: Indwelling Fecal Management System, Bowel Management Systems, LLC (2002) Summary page 1.

## Most influential descendants
- K150350: Flexi-Seal Signal Fecal Management System (2015), 6 descendants of its own
- K162906: Flexi-Seal PROTECT Fecal Management System (2017), 2 descendants of its own
- K221400: hygh-tec drainage (2023), 1 descendant of its own
- K190114: Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) (2019), 1 descendant of its own
- K243228: Flexi-Seal AIR (with ENFit Connector) (2025), 0 descendants of its own

## Indications for use
For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications.

Source page: https://510kreport.com/device/K112342
Methodology: https://510kreport.com/methodology