Cleared Traditional

K972455 - JIMMY JOHN III RECTAL NOZZEL, MODEL CIT

K972455 is an FDA 510(k) clearance for JIMMY JOHN III RECTAL NOZZEL, manufactured by Colon Therapeutics. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K972455 · Colon Therapeutics · Gastroenterology & Urology device
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Sep 1997
Decision
70d
Days
Class 2
Risk

K972455 is an FDA 510(k) clearance for the JIMMY JOHN III RECTAL NOZZEL, MODEL CIT. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Colon Therapeutics (Groves, US). The FDA issued a Cleared decision on September 9, 1997 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Colon Therapeutics devices

FDA 510(k) Submission Details - K972455

510(k) Number K972455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1997
Decision Date September 09, 1997
Days to Decision 70 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
61d faster than avg
Panel avg: 131d · This submission: 70d
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 16
Devices cleared under the same product code (KPL) and FDA review panel - the closest regulatory comparables to K972455.
GC IRRIGATOR
K980868 · Gentle Colonics, Inc. · Aug 1998
TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
K970482 · Srs Intl. · Oct 1997
JIMMY JOHN III RECTAL NOZZLE
K973256 · Colon Therapeutics · Sep 1997
LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
K962259 · Tiller Mind Body, Inc. · Aug 1996
CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
K942867 · Clearwater Colon Hydrotherapy, Inc. · Jun 1996
CUFF SPECULUM
K893531 · Mountain Medical Equipment, Inc. · Jun 1989