Cleared Special

K111648 - BRACCO DIAGNOSTICS

K111648 is an FDA 510(k) clearance for BRACCO DIAGNOSTICS, manufactured by Bracco Diagnostic, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCX cleared through the Special 510(k) pathway after a 143-day FDA review.

K111648 · Bracco Diagnostic, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
143d
Days
Class 2
Risk

K111648 is an FDA 510(k) clearance for the BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by Bracco Diagnostic, Inc. (Melville, US). The FDA issued a Cleared decision on November 3, 2011 after a review of 143 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bracco Diagnostic, Inc. devices

FDA 510(k) Submission Details - K111648

510(k) Number K111648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2011
Decision Date November 03, 2011
Days to Decision 143 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 130d · This submission: 143d
Pathway characteristics
Modification to existing cleared device.

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 K111648.
BAROnova Insufflation System, BAROnova Accessory Kit
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K030854 · E-Z-Em, Inc. · Apr 2003