Cleared Traditional

K123047 - BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET

K123047 is an FDA 510(k) clearance for BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC ..., 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 312-day FDA review.

K123047 · Bracco Diagnostic, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
312d
Days
Class 2
Risk

K123047 is an FDA 510(k) clearance for the BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by Bracco Diagnostic, Inc. (Princeton, US). The FDA issued a Cleared decision on August 6, 2013 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K123047

510(k) Number K123047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2012
Decision Date August 06, 2013
Days to Decision 312 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 131d · This submission: 312d
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 21
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K123047.
Nexcore GI Insufflator
K162332 · Nexcore Technology, LLC · Sep 2016
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976 · Fujifilm Medical System U.S.A., Inc. · Sep 2014
BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR
K132192 · Bracco Diagnostic, Inc. · Feb 2014
ENDOGATER AVANTAGE CO2 INSUFFLATOR
K113310 · Byrne Medical, Inc. · Jun 2012
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
K111648 · Bracco Diagnostic, Inc. · Nov 2011
INSUFLOW CO2IONSHIELD
K090879 · Lexion Medical, LLC · Jul 2009