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 · EZQ Pouch, Colostomy
Cleared on Apr 2, 2010 as substantially equivalent to K863830 (Coloplast A/S, 1986) after a 469-day review. Its family tree reaches back 1 generation to 1986. 2 later devices descend from it.
- Decided
- Apr 2, 2010
- Review
- 469 days
- Class
- Class I
- Product code
- EZQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863830 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK863830 Conseal (TM) Colostomy Continence SystemColoplast A/S · 1986
- This deviceK083785 Vitala Continence Control DeviceConvatec · 2010
- Descendant · cites it directly · 1 of its ownK102536 Vitala Continence Control DeviceConvatec, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK111365 Vitala Continence Control DeviceConvatec, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863830 | Conseal (TM) Colostomy Continence System | Coloplast A/S | 1986 | — |
| 0 (this device) | K083785 | Vitala Continence Control Device | Convatec | 2010 | — |
| +1 | K102536 | Vitala Continence Control Device | Convatec, Inc. | 2010 | — |
| +1 | K111365 | Vitala Continence Control Device | Convatec, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
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? (1)
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 |
|---|---|---|---|
| * | K863830 | Conseal (TM) Colostomy Continence SystemSummary page 1…Product Code: EZQ - C.F.R. Section 876.5900 Substantially Equivalent Device: Coloplast Conseal Colostomy Continence System (1(863830) The VitalaTM Continence Control Device is a pouchless ostomy device consisting of a self-inflating… | 1986 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K102536 (Convatec, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EZQ devicesEZQ Pouch, Colostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083785: Vitala Continence Control Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083785
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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