Cleared Traditional

K151345 - BioGuard Air/Water Valve

K151345 is the FDA 510(k) clearance for BioGuard Air/Water Valve by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code ODC) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K151345 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Aug 2015
Decision
98d
Days
Class 2
Risk

K151345 is an FDA 510(k) clearance for the BioGuard Air/Water Valve, BioGuard Suction Valve. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on August 25, 2015 after a review of 98 days - within the typical 510(k) review window.

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 United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K151345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2015
Decision Date August 25, 2015
Days to Decision 98 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
32d faster than avg
Panel avg: 130d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODC Endoscope Channel Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Give The Endoscope Channel Additional Or Improved Functionality.
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 - ODC Endoscope Channel Accessory

All 49
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K151345.
San Antonio Stopcock
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K112698 · United States Endoscopy Group, Inc. · May 2012
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431
K073484 · Ethicon Endo-Surgery, Inc. · Mar 2008
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · Boston Scientific Corp · Mar 2001