Cleared Traditional

K050112 - PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117

K050112 is an FDA 510(k) clearance for PRO FIT DISPOSABLE RECTAL SPECULUM, manufactured by Prime Pacific Health Innovations Corporation. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K050112 · Prime Pacific Health Innovations Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
56d
Days
Class 2
Risk

K050112 is an FDA 510(k) clearance for the PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Prime Pacific Health Innovations Corporation (North Vancouver, Bc, CA). The FDA issued a Cleared decision on March 15, 2005 after a review of 56 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 Prime Pacific Health Innovations Corporation devices

FDA 510(k) Submission Details - K050112

510(k) Number K050112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date March 15, 2005
Days to Decision 56 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
75d faster than avg
Panel avg: 131d · This submission: 56d
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 K050112.
COLONIC & ENEMA NOZZLE
K071057 · Tiller Mind Body, Inc. · Oct 2007
COLONIC AND ENEMA NOZZLE
K051344 · Ultimate Concepts, Inc. · Aug 2005
CONMED IRRIGATION NOZZLE
K050992 · Conmedcorp · Jul 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