Cleared Traditional

SmartStart Air/Water and Suction Valves (K160403) - FDA 510(k) Clearance

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

K160403 · Endochoice, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 2016
Decision
97d
Days
Class 2
Risk

K160403 is an FDA 510(k) clearance for the SmartStart Air/Water and Suction Valves. Classified as Endoscope Channel Accessory (product code ODC), Class II - Special Controls.

Submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on May 19, 2016 after a review of 97 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 Endochoice, Inc. devices

Submission Details

510(k) Number K160403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2016
Decision Date May 19, 2016
Days to Decision 97 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
33d faster than avg
Panel avg: 130d · This submission: 97d
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 50
Devices cleared under the same product code (ODC) and FDA review panel - the closest regulatory comparables to K160403.
San Antonio Stopcock
K181712 · Cook Incorporated · Jul 2018
Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
K173105 · Cook Incorporated · Mar 2018
Accessory Irrigation Adapter
K162142 · Wilson-Cook Medical, Inc. · Apr 2017
BioGuard Air/Water Valve, BioGuard Suction Valve
K151345 · United States Endoscopy Group, Inc. · Aug 2015
CONCENTRIC BALLOON GOOGLE
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