Cleared Traditional

K090879 - INSUFLOW CO2IONSHIELD

K090879 is the FDA 510(k) clearance for INSUFLOW CO2IONSHIELD by Lexion Medical, LLC. It is a Class 2 Gastroenterology & Urology device (product code FCX) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K090879 · Lexion Medical, LLC · Gastroenterology & Urology device
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Jul 2009
Decision
114d
Days
Class 2
Risk

K090879 is an FDA 510(k) clearance for the INSUFLOW CO2IONSHIELD. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by Lexion Medical, LLC (St. Paul, US). The FDA issued a Cleared decision on July 23, 2009 after a review of 114 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 Lexion Medical, LLC devices

Submission Details

510(k) Number K090879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2009
Decision Date July 23, 2009
Days to Decision 114 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
16d faster than avg
Panel avg: 130d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FCX Insufflator, Automatic Carbon-dioxide For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - FCX Insufflator, Automatic Carbon-dioxide For Endoscope

All 14
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K090879.
BAROnova Insufflation System, BAROnova Accessory Kit
K190985 · Baronova, Inc. · May 2019
FUJIFILM Endoscopic CO2 Regulator GW-100
K180711 · Fujifilm Corporation · May 2018
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976 · Fujifilm Medical System U.S.A., Inc. · Sep 2014
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
K063786 · Olympus Medical Systems Corporation · Mar 2007
E-Z-EM ENDOSCOPIC CO2 REGULATOR
K053008 · E-Z-Em, Inc. · Dec 2005
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854 · E-Z-Em, Inc. · Apr 2003