Cleared Special

K030854 - PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400

K030854 is an FDA 510(k) clearance for PROTOCO2L COLON INSUFFLATOR WITH PERFOR..., manufactured by E-Z-Em, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCX cleared through the Special 510(k) pathway after a 29-day FDA review.

K030854 · E-Z-Em, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
29d
Days
Class 2
Risk

K030854 is an FDA 510(k) clearance for the PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on April 16, 2003 after a review of 29 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K030854

510(k) Number K030854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2003
Decision Date April 16, 2003
Days to Decision 29 days
Submission Type Special
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
102d faster than avg
Panel avg: 131d · This submission: 29d
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 24
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K030854.
INSUFLOW CO2IONSHIELD
K090879 · Lexion Medical, LLC · Jul 2009
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 INSUFFLATOR MODEL 6400
K013219 · E-Z-Em, Inc. · Feb 2002
INSUFFLATOR FILTER TUBING SET
K945970 · Xylog Corp. · Dec 1994
E-Z-FLATE
K930581 · E-Z-Em, Inc. · Jul 1994
K030854 · PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
Download PDF FDA Summary E-Z-Em, Inc.