510(k) Report

510(k) · Cleared

Cleared

Marlen Ultra Ileostomy Pouch-5000

K880327510(k) TraditionalCleared Feb 19, 198824-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

Marlen Mfg. & Development Co. · EZQ Pouch, Colostomy

Cleared on Feb 19, 1988 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 19, 1988
Review
24 days
Class
Class I
Product code
EZQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K880327Source: FDA 510(k) database · How lineage is built

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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
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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?

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.

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—

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
  • K863830Conseal (TM) Colostomy Continence SystemColoplast A/S · 1986

https://510kreport.com/device/K880327 · printed Nov 6, 2026

Cite this page

510(k) Report. “K880327: Marlen Ultra Ileostomy Pouch-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880327

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