Cleared Traditional

K033149 - ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM

K033149 is an FDA 510(k) clearance for ULTIMATE PROFESSIONAL CONTINUOUS FLOW C..., manufactured by Ultimate Concepts, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K033149 · Ultimate Concepts, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
175d
Days
Class 2
Risk

K033149 is an FDA 510(k) clearance for the ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Ultimate Concepts, Inc. (Irvine, US). The FDA issued a Cleared decision on March 23, 2004 after a review of 175 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.

View all Ultimate Concepts, Inc. devices

FDA 510(k) Submission Details - K033149

510(k) Number K033149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date March 23, 2004
Days to Decision 175 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 131d · This submission: 175d
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 K033149.
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