Cleared Traditional

K002102 - GENTLE COLONICS IRRIGATION SYSTEM

K002102 is an FDA 510(k) clearance for GENTLE COLONICS IRRIGATION SYSTEM, manufactured by Gentle Colonics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 574-day FDA review.

K002102 · Gentle Colonics, Inc. · Gastroenterology & Urology device
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Feb 2002
Decision
574d
Days
Class 2
Risk

K002102 is an FDA 510(k) clearance for the GENTLE COLONICS IRRIGATION SYSTEM. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Gentle Colonics, Inc. (Irvine, US). The FDA issued a Cleared decision on February 6, 2002 after a review of 574 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Gentle Colonics, Inc. devices

FDA 510(k) Submission Details - K002102

510(k) Number K002102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2000
Decision Date February 06, 2002
Days to Decision 574 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
443d slower than avg
Panel avg: 131d · This submission: 574d
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 20
Devices cleared under the same product code (KPL) and FDA review panel - the closest regulatory comparables to K002102.
COLONIC AND ENEMA NOZZLE
K051344 · Ultimate Concepts, Inc. · Aug 2005
CONMED IRRIGATION NOZZLE
K050992 · Conmedcorp · Jul 2005
PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
K050112 · Prime Pacific Health Innovations Corporation · Mar 2005
AQUANET, MODEL EC 2000
K000031 · Prime Pacific Health Innovations Corporation · Sep 2001
CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
K000388 · Clearwater Colon Hydrotherapy, Inc. · Aug 2000
GC IRRIGATOR
K980868 · Gentle Colonics, Inc. · Aug 1998