Cleared Traditional

K970482 - TRANSCOM COLON HYDROTHERAPY MODEL HC-2000

K970482 is an FDA 510(k) clearance for TRANSCOM COLON HYDROTHERAPY MODEL HC-2000, manufactured by Srs Intl.. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K970482 · Srs Intl. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
263d
Days
Class 2
Risk

K970482 is an FDA 510(k) clearance for the TRANSCOM COLON HYDROTHERAPY MODEL HC-2000. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Srs Intl. (Washington, US). The FDA issued a Cleared decision on October 31, 1997 after a review of 263 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 Srs Intl. devices

FDA 510(k) Submission Details - K970482

510(k) Number K970482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1997
Decision Date October 31, 1997
Days to Decision 263 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
132d slower than avg
Panel avg: 131d · This submission: 263d
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 K970482.
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
JIMMY JOHN III RECTAL NOZZLE
K973256 · Colon Therapeutics · Sep 1997
JIMMY JOHN III RECTAL NOZZEL, MODEL CIT
K972455 · Colon Therapeutics · Sep 1997
LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
K962259 · Tiller Mind Body, Inc. · Aug 1996