Cleared Traditional

K152834 - Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10

K152834 is an FDA 510(k) clearance for Colonplus Colonkit small, manufactured by Colonplus Equipments & Speculums, S.L.. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K152834 · Colonplus Equipments & Speculums, S.L. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
316d
Days
Class 2
Risk

K152834 is an FDA 510(k) clearance for the Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with S.... Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Colonplus Equipments & Speculums, S.L. (San Sebastian (Guipuzcoa), ES). The FDA issued a Cleared decision on August 10, 2016 after a review of 316 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Colonplus Equipments & Speculums, S.L. devices

FDA 510(k) Submission Details - K152834

510(k) Number K152834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2015
Decision Date August 10, 2016
Days to Decision 316 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
185d slower than avg
Panel avg: 131d · This submission: 316d
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 Consultant

Business Excellence Consulting, Inc.
Solmarie Velez Rivera

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K152834.
Bio Fluff System
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THE WATER LILY
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COLONIC & ENEMA NOZZLE
K071057 · Tiller Mind Body, Inc. · Oct 2007