Cleared Traditional

K180800 - Colonic Plus Regular, Small, and Straight Shape Hydrokit

K180800 is an FDA 510(k) clearance for Colonic Plus Regular, manufactured by Colonic Plus. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K180800 · Colonic Plus · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
66d
Days
Class 2
Risk

K180800 is an FDA 510(k) clearance for the Colonic Plus Regular, Small, and Straight Shape Hydrokit. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Colonic Plus (Palm Desert, US). The FDA issued a Cleared decision on June 1, 2018 after a review of 66 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 Colonic Plus devices

FDA 510(k) Submission Details - K180800

510(k) Number K180800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 27, 2018
Decision Date June 01, 2018
Days to Decision 66 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
65d faster than avg
Panel avg: 131d · This submission: 66d
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 K180800.
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