510(k) Report

510(k) · Cleared

Cleared

Palex Irrigation Set

K904586510(k) TraditionalCleared Dec 28, 199080-day reviewClass II21 CFR 876.5895

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

Palex Intl. SA · EXD Irrigator, Ostomy

Cleared on Dec 28, 1990 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 28, 1990
Review
80 days
Class
Class II
Product code
EXD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K904586Source: 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.

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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 EXD devices

EXD Irrigator, Ostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EXD

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EXD

Too few EXD 510(k)s in any year since 2007 to give a median.

Recalls per year · EXD

No recall names EXD since 2007.

Adverse event reports per year · EXD

1in 2021

2008: 22014: 22015: 32016: 12018: 302021: 1
2007high 30 (2018) · low 0 (2007)2025

MAUDE reports naming product code EXD, 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—00
20080—02
20090—00
20100—00
20110—00
20121—00
20130—00
20140—02
20150—03
20160—01
20170—00
20180—030
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Palex Intl. SA

5 FDA decisions under this applicant name. See the company

  • K905108Contorno (R), Models E and STPalex Intl. SA · 1991
  • K903224EpisensorPalex Intl. SA · 1990
  • K902642Contorno (TM)Palex Intl. SA · 1990
  • K901680Bauman Rigid LaryngoscopePalex Intl. SA · 1990

Recent decisions in EXD

The EXD category page

  • K121833Ostomy Irrigation SetColoplast A/S · 2012
  • K914692Urinary Diversion Evacuating CatheterCook Urological, Inc. · 1992
  • K871791Bloxom IrrigatorI.B. Bloxom C/O Hogan & Hartson · 1987
  • K840268Irrigation SystemColoplast A/S · 1984
  • K832299Visi-Flow IrrigatorConvatec, A Division of E.R. Squibb & Sons · 1983

https://510kreport.com/device/K904586 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904586: Palex Irrigation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904586

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