# K032734: Convatec Fecal Management System

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, A Bristol-Myers Squibb Co.
- Decided: Apr 8, 2004 after 217 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K813526 (1982). 3 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012113: Indwelling Fecal Management System, Bowel Management Systems, LLC (2002)

## Most influential descendants
- K112342: Flexi-Seal Signal Fecal Management System (2012), 8 descendants of its own
- K150350: Flexi-Seal Signal Fecal Management System (2015), 6 descendants of its own
- K073598: Bard Dignicare Stool Management System (2008), 5 descendants of its own
- K102391: Bard Dignishield Stool Management System (2010), 4 descendants of its own
- K162906: Flexi-Seal PROTECT Fecal Management System (2017), 2 descendants of its own

## Recalls of this device
- Jun 25, 2013 · Class III · Z-1990-2013: ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number
- Jun 25, 2013 · Class III · Z-1991-2013: ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number
- Nov 20, 2008 · Not classified · Z-0618-2009: It was discovered that a portion of the inner nylon sleeve of the catheter was visible at the balloon end of a sample device.

## Indications for use
For the fecal management of patients with little or no bowel control and for patients whose stool is semi-liquid or liquid

Source page: https://510kreport.com/device/K032734
Methodology: https://510kreport.com/methodology