Cleared Traditional

K003720 - ANGEL OF WATER COLON HYDROTHERAPY SYSTEM

K003720 is an FDA 510(k) clearance for ANGEL OF WATER COLON HYDROTHERAPY SYSTEM, manufactured by Lifestream Purfication Systems, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 570-day FDA review.

K003720 · Lifestream Purfication Systems, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
570d
Days
Class 2
Risk

K003720 is an FDA 510(k) clearance for the ANGEL OF WATER COLON HYDROTHERAPY SYSTEM. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Lifestream Purfication Systems, LLC (Fort Worth, US). The FDA issued a Cleared decision on June 27, 2002 after a review of 570 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 Lifestream Purfication Systems, LLC devices

FDA 510(k) Submission Details - K003720

510(k) Number K003720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date June 27, 2002
Days to Decision 570 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
439d slower than avg
Panel avg: 131d · This submission: 570d
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 21
Devices cleared under the same product code (KPL) and FDA review panel - the closest regulatory comparables to K003720.
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
GENTLE COLONICS IRRIGATION SYSTEM
K002102 · Gentle Colonics, Inc. · Feb 2002
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