Cleared Traditional

AQUANET, MODEL EC 2000 (K000031) - FDA 510(k) Clearance

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

K000031 · Prime Pacific Health Innovations Corporation · Gastroenterology & Urology device
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Sep 2001
Decision
614d
Days
Class 2
Risk

K000031 is an FDA 510(k) clearance for the AQUANET, MODEL EC 2000. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Prime Pacific Health Innovations Corporation (North Vancouver, CA). The FDA issued a Cleared decision on September 10, 2001 after a review of 614 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Prime Pacific Health Innovations Corporation devices

Submission Details

510(k) Number K000031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2000
Decision Date September 10, 2001
Days to Decision 614 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
484d slower than avg
Panel avg: 130d · This submission: 614d
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.