Cleared Traditional

K840613 - COLON IRRIGATION UNIT

K840613 is an FDA 510(k) clearance for COLON IRRIGATION UNIT, manufactured by Colenz Co.. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K840613 · Colenz Co. · Gastroenterology & Urology device
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Jul 1984
Decision
155d
Days
Class 2
Risk

K840613 is an FDA 510(k) clearance for the COLON IRRIGATION UNIT. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Colenz Co. (Mchenry, US). The FDA issued a Cleared decision on July 17, 1984 after a review of 155 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5220 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K840613

510(k) Number K840613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1984
Decision Date July 17, 1984
Days to Decision 155 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
24d slower than avg
Panel avg: 131d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPL Device Classification - Class 2, Special Controls

Product Code KPL Colonic Irrigation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5220
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 - KPL Colonic Irrigation System

All 24
Devices cleared under the same product code (KPL) and FDA review panel - the closest regulatory comparables to K840613.
CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
K942867 · Clearwater Colon Hydrotherapy, Inc. · Jun 1996
LOWER BOWEL EVACUATION SYSTEM
K941279 · Tiller Mind Body, Inc. · Oct 1995
CUFF SPECULUM
K893531 · Mountain Medical Equipment, Inc. · Jun 1989
SARNS INFANT ARTERIAL BUBBLE SENSOR
K803105 · 3M Health Care, Sarns · Dec 1980