Cleared Traditional

K132192 - BRACCO DIAGNOSTICS INC. PROTOCO

K132192 is an FDA 510(k) clearance for BRACCO DIAGNOSTICS INC. PROTOCO, manufactured by Bracco Diagnostic, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCX cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K132192 · Bracco Diagnostic, Inc. · Gastroenterology & Urology device
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Feb 2014
Decision
214d
Days
Class 2
Risk

K132192 is an FDA 510(k) clearance for the BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by Bracco Diagnostic, Inc. (Monroe Township, US). The FDA issued a Cleared decision on February 14, 2014 after a review of 214 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 Bracco Diagnostic, Inc. devices

FDA 510(k) Submission Details - K132192

510(k) Number K132192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2013
Decision Date February 14, 2014
Days to Decision 214 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
84d slower than avg
Panel avg: 130d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCX Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K132192.
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