Cleared Traditional

PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 (K050112) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050112 · Prime Pacific Health Innovations Corporation · Gastroenterology & Urology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 130d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.