Cleared Traditional

K904586 - PALEX IRRIGATION SET

K904586 is the FDA 510(k) clearance for PALEX IRRIGATION SET by Palex Intl. SA. It is a Class 2 Gastroenterology & Urology device (product code EXD) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K904586 · Palex Intl. SA · Gastroenterology & Urology device
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Dec 1990
Decision
80d
Days
Class 2
Risk

K904586 is an FDA 510(k) clearance for the PALEX IRRIGATION SET. Classified as Irrigator, Ostomy (product code EXD), Class II - Special Controls.

Submitted by Palex Intl. SA (Spain, ES). The FDA issued a Cleared decision on December 28, 1990 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5895 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Palex Intl. SA devices

Submission Details

510(k) Number K904586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1990
Decision Date December 28, 1990
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EXD Irrigator, Ostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - EXD Irrigator, Ostomy

Devices cleared under the same product code (EXD) and FDA review panel - the closest regulatory comparables to K904586.
OSTOMY IRRIGATION SET
K121833 · Coloplast A/S · Jul 2012
URINARY DIVERSION EVACUATING CATHETER
K914692 · Cook Urological, Inc. · Jul 1992
IRRIGATION SYSTEM
K840268 · Coloplast A/S · Apr 1984
VISI-FLOW IRRIGATOR
K832299 · Convatec, A Division of E.R. Squibb & Sons · Aug 1983
UNI-TIP COLOSTOMY IRRIGATION CONE
K823274 · Howmedica Corp. · Dec 1982