Cleared Traditional

K131426 - MEDLINE BIOPSY VALVE

K131426 is an FDA 510(k) clearance for MEDLINE BIOPSY VALVE, manufactured by Medline Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCX cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K131426 · Medline Industries, Inc. · Gastroenterology & Urology device
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Feb 2014
Decision
280d
Days
Class 2
Risk

K131426 is an FDA 510(k) clearance for the MEDLINE BIOPSY VALVE. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 21, 2014 after a review of 280 days - an extended review cycle.

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. 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 Medline Industries, Inc. devices

FDA 510(k) Submission Details - K131426

510(k) Number K131426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2013
Decision Date February 21, 2014
Days to Decision 280 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 131d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCX Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K131426.
US ENDOSCOPY DISTAL ATTACHMENT CAP
K140315 · United States Endoscopy Group, Inc. · Apr 2014
SEAL SINGLE-USE BIOPSY VALVE
K133734 · Endochoice, Inc. · Mar 2014
TORRENT IRRIGATION SYSTEM
K140405 · United States Endoscopy Group, Inc. · Mar 2014
SEAL BIOPSY VALVE - REUSABLE
K132776 · Endochoice, Inc. · Dec 2013
GATEWAY ADVANAGE Y-ADAPTER
K130909 · Boston Scientific Corp · May 2013
CLEARPATH 24
K112318 · Promedic, Inc. · Jun 2012