# K111365: Vitala Continence Control Device

- Pathway: 510(k) (Traditional)
- Applicant: Convatec, Inc.
- Decided: Aug 19, 2011 after 95 days
- Product code: EZQ (Pouch, Colostomy)
- Device class: 1
- Regulation: 21 CFR 876.5900
- 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 K863830 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102536: Vitala Continence Control Device, Convatec, Inc. (2010) Summary page 1.
- K083785: Vitala Continence Control Device, Convatec (2010) Summary page 1.

## Indications for use
The VITALATM Continence Control Device is a single-use device intended to prevent the release of stool from an end colostomy while allowing any flatus from the stoma to be deodorized and released. To be used only with a 1 3/4 in. (45 mm) or 2 1/4 in. (57 mm) ConvaTec NATURA® skin barrier.

Source page: https://510kreport.com/device/K111365
Methodology: https://510kreport.com/methodology