510(k) Report

510(k) · Cleared

Cleared

Conseal (TM) Colostomy Continence System

K863830510(k) TraditionalCleared Oct 16, 198616-day reviewClass I21 CFR 876.5900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Coloplast A/S · EZQ Pouch, Colostomy

Cleared on Oct 16, 1986 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Oct 16, 1986
Review
16 days
Class
Class I
Product code
EZQ
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 2 descendants cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK863830 Conseal (TM) Colostomy Continence SystemColoplast A/S · 1986
  2. Descendant · cites it directly · 2 of its ownK083785 Vitala Continence Control DeviceConvatec · 2010
  3. Descendant · 2 generations on · 1 of its ownK102536 Vitala Continence Control DeviceConvatec, Inc. · 2010
  4. Descendant · 2 generations on · 0 of its ownK111365 Vitala Continence Control DeviceConvatec, Inc. · 2011

Most influential descendants

Showing 3 of 3 · See all
  • K083785Vitala Continence Control DeviceConvatec · 2010 · cites it directly2descendants
  • K102536Vitala Continence Control DeviceConvatec, Inc. · 2010 · 2 generations on1descendant
  • K111365Vitala Continence Control DeviceConvatec, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K863830Conseal (TM) Colostomy Continence SystemColoplast A/S1986—
+1K083785Vitala Continence Control DeviceConvatec2010—
+2K102536Vitala Continence Control DeviceConvatec, Inc.2010—
+2K111365Vitala Continence Control DeviceConvatec, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201020
201110
FIG. 1 — Lineage of K863830, 1986–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083785Vitala Continence Control DeviceConvatec20102

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?

  • Of its descendants, K083785 (Convatec, 2010) has gone furthest, with 2 descendants of its own.

How does its category compare?

All EZQ devices

EZQ Pouch, Colostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EZQ

1in 2011

2010: 22011: 1
2007high 2 (2010) · low 0 (2007)2026

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

2010: 12022: 4
2007high 4 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EZQ

104in 2025

2007: 12008: 12009: 12010: 12011: 32012: 22013: 832014: 2482015: 1602016: 662017: 72018: 3422019: 2462020: 3812021: 1182022: 942023: 902024: 532025: 104
2007high 381 (2020) · low 1 (2007)2025

MAUDE reports naming product code EZQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—01
20090—01
20102—11
20111—03
20120—02
20130—083
20140—0248
20150—0160
20160—066
20170—07
20180—0342
20190—0246
20200—0381
20210—0118
20220—494
20230—090
20240—053
20250—0104
20260—0—

More from Coloplast A/S

71 FDA decisions under this applicant name. See the company

  • K221874Altis Single Incision Sling SystemColoplast A/S · 2023
  • K220420Saffron Fixation SystemColoplast A/S · 2022
  • K191536Biatain Silicone AgColoplast A/S · 2020
  • K181811ReTrace Ureteral Access SheathColoplast A/S · 2018
  • K173527Digitex Delivery DeviceColoplast A/S · 2018

Recent decisions in EZQ

The EZQ category page

  • K111365Vitala Continence Control DeviceConvatec, Inc. · 2011
  • K102536Vitala Continence Control DeviceConvatec, Inc. · 2010
  • K083785Vitala Continence Control DeviceConvatec · 2010
  • K9224014 Sure TM Colostomy PouchBoston Pacific Medical, Inc. · 1992
  • K880327Marlen Ultra Ileostomy Pouch-5000Marlen Mfg. & Development Co. · 1988

https://510kreport.com/device/K863830 · printed Nov 6, 2026

Cite this page

510(k) Report. “K863830: Conseal (TM) Colostomy Continence System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863830

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026