Cleared Traditional

CLEARPATH 24 (K112318) - FDA 510(k) Clearance

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

K112318 · Promedic, Inc. · Gastroenterology & Urology device
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Jun 2012
Decision
323d
Days
Class 2
Risk

K112318 is an FDA 510(k) clearance for the CLEARPATH 24. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Promedic, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on June 29, 2012 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Promedic, Inc. devices

Submission Details

510(k) Number K112318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2011
Decision Date June 29, 2012
Days to Decision 323 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
193d slower than avg
Panel avg: 130d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
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 - OCX Endoscopic Irrigation/suction System

All 47
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K112318.
OpClear System
K171637 · Cipher Surgical, Ltd. · Feb 2018
MEDLINE BIOPSY VALVE
K131426 · Medline Industries, Inc. · Feb 2014
GATEWAY ADVANAGE Y-ADAPTER
K130909 · Boston Scientific Corp · May 2013
ENDOMAT LC PUMP, MODEL 20 3303 20
K031457 · KARL STORZ Endoscopy-America, Inc. · Apr 2004
BARD(R) SYRINGE ASSIST IRRIGATION
K905102 · C.R. Bard, Inc. · Apr 1991
MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION
K883173 · KARL STORZ Endoscopy-America, Inc. · Oct 1988