# K150350: Flexi-Seal Signal Fecal Management System

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, Ltd.
- Decided: Jul 21, 2015 after 160 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). 5 ancestors in all.
6 later devices descend from it; 3 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)
- K112342: Flexi-Seal Signal Fecal Management System, Convatec, Inc. (2012) Summary page 4.

## Most influential descendants
- 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
- K242336: hygh-tec Drainage II (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/K150350
Methodology: https://510kreport.com/methodology