510(k) · Cleared
ClearedVitala Continence Control Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, Inc. · EZQ Pouch, Colostomy
Cleared on Aug 19, 2011 as substantially equivalent to K102536 (Convatec, Inc., 2010) and 1 other predicate after a 95-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Aug 19, 2011
- Review
- 95 days
- Class
- Class I
- Product code
- EZQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K863830 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK863830 Conseal (TM) Colostomy Continence SystemColoplast A/S · 1986
- 2 generations backK083785 Vitala Continence Control DeviceConvatec · 2010
- 1 generation backK102536 Vitala Continence Control DeviceConvatec, Inc. · 2010
- This deviceK111365 Vitala Continence Control DeviceConvatec, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102536 | Vitala Continence Control DeviceSummary page 1…876.5900; Product Code EZQ) Device Class: Class 1 510(k) Substantial Equivalence: K102536 -determined substantially equivalent on December 1,2010… | 2010 |
| * | K083785 | Vitala Continence Control DeviceSummary page 1…valence: K102536 -determined substantially equivalent on December 1,2010 K083785 - determined substantially equivalent on April 2, 2010 The VitalaTM Continence… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All EZQ devicesEZQ Pouch, Colostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · EZQ
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · EZQ
Too few EZQ 510(k)s in any year since 2007 to give a median.
Recalls per year · EZQ
4in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZQ
104in 2025
MAUDE reports naming product code EZQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 83 |
| 2014 | 0 | — | 0 | 248 |
| 2015 | 0 | — | 0 | 160 |
| 2016 | 0 | — | 0 | 66 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 342 |
| 2019 | 0 | — | 0 | 246 |
| 2020 | 0 | — | 0 | 381 |
| 2021 | 0 | — | 0 | 118 |
| 2022 | 0 | — | 4 | 94 |
| 2023 | 0 | — | 0 | 90 |
| 2024 | 0 | — | 0 | 53 |
| 2025 | 0 | — | 0 | 104 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111365 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111365: Vitala Continence Control Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111365
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026