Cleared Traditional

K840268 - IRRIGATION SYSTEM

K840268 is an FDA 510(k) clearance for IRRIGATION SYSTEM, manufactured by Coloplast A/S. The device is a Class 2 Gastroenterology & Urology device with product code EXD cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K840268 · Coloplast A/S · Gastroenterology & Urology device
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Apr 1984
Decision
73d
Days
Class 2
Risk

K840268 is an FDA 510(k) clearance for the IRRIGATION SYSTEM. Classified as Irrigator, Ostomy (product code EXD), Class II - Special Controls.

Submitted by Coloplast A/S (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 73 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 Coloplast A/S devices

FDA 510(k) Submission Details - K840268

510(k) Number K840268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date April 05, 1984
Days to Decision 73 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 131d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EXD Device Classification - Class 2, Special Controls

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

All 7
Devices cleared under the same product code (EXD) and FDA review panel - the closest regulatory comparables to K840268.
OSTOMY IRRIGATION SET
K121833 · Coloplast A/S · Jul 2012
URINARY DIVERSION EVACUATING CATHETER
K914692 · Cook Urological, Inc. · Jul 1992
VISI-FLOW IRRIGATOR
K832299 · Convatec, A Division of E.R. Squibb & Sons · Aug 1983
UNI-TIP COLOSTOMY IRRIGATION CONE
K823274 · Howmedica Corp. · Dec 1982
SUR-FIT IRRIGATION SLEEVE
K811160 · E. R. Squibb & Sons, Inc. · Jun 1981
TUBE, GASTRO-ENTEROSTOMY
K760810 · Sherwood Medical Industries · Feb 1977