# K083785: Vitala Continence Control Device

- Pathway: 510(k) (Traditional)
- Applicant: Convatec
- Decided: Apr 2, 2010 after 469 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: 1 generation back to K863830 (1986). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863830: Conseal (TM) Colostomy Continence System, Coloplast A/S (1986) Summary page 1.

## Most influential descendants
- K102536: Vitala Continence Control Device (2010), 1 descendant of its own
- K111365: Vitala Continence Control Device (2011), 0 descendants of its own

## Indications for use
To prevent the release of stool from an end colostomy while allowing any gas that is present at the stoma to be deodorized and released. To be used only with a 1 1/4' (45 mm) or 2 1/4" (57 mm) ConvaTec Natura® skin barrier. Not intended for use with ConvaTec Moldable Technology™ skin barriers or convex products.

Source page: https://510kreport.com/device/K083785
Methodology: https://510kreport.com/methodology