Cleared Traditional

K131852 - HC-1 AND HC-1 CLASSIC

K131852 is an FDA 510(k) clearance for HC-1 AND HC-1 CLASSIC, manufactured by Transcendencias Comerciales SL Transcom. The device is a Class 2 Gastroenterology & Urology device with product code KPL cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K131852 · Transcendencias Comerciales SL Transcom · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
300d
Days
Class 2
Risk

K131852 is an FDA 510(k) clearance for the HC-1 AND HC-1 CLASSIC. Classified as Colonic Irrigation System (product code KPL), Class II - Special Controls.

Submitted by Transcendencias Comerciales SL Transcom (San Sebastian, Guipuzcoa, ES). The FDA issued a Cleared decision on April 17, 2014 after a review of 300 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. Standard predicate reliance. 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 Transcendencias Comerciales SL Transcom devices

FDA 510(k) Submission Details - K131852

510(k) Number K131852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2013
Decision Date April 17, 2014
Days to Decision 300 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
169d slower than avg
Panel avg: 131d · This submission: 300d
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 K131852.
Colonic Plus Regular, Small, and Straight Shape Hydrokit
K180800 · Colonic Plus · Jun 2018
Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
K152834 · Colonplus Equipments & Speculums, S.L. · Aug 2016
AQUA CLEANSE
K150381 · Quality Medical Supply, Inc. · Sep 2015
THE WATER LILY
K094022 · Clearwater Products, LLC · Jun 2010
COLONIC & ENEMA NOZZLE
K071057 · Tiller Mind Body, Inc. · Oct 2007
COLONIC AND ENEMA NOZZLE
K051344 · Ultimate Concepts, Inc. · Aug 2005