Cleared Abbreviated

K053008 - E-Z-EM ENDOSCOPIC CO2 REGULATOR

K053008 is an FDA 510(k) clearance for E-Z-EM ENDOSCOPIC CO2 REGULATOR, manufactured by E-Z-Em, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCX cleared through the Abbreviated 510(k) pathway after a 62-day FDA review.

K053008 · E-Z-Em, Inc. · Gastroenterology & Urology device
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Dec 2005
Decision
62d
Days
Class 2
Risk

K053008 is an FDA 510(k) clearance for the E-Z-EM ENDOSCOPIC CO2 REGULATOR. 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 December 27, 2005 after a review of 62 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all E-Z-Em, Inc. devices

FDA 510(k) Submission Details - K053008

510(k) Number K053008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2005
Decision Date December 27, 2005
Days to Decision 62 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 131d · This submission: 62d
Pathway characteristics
Standards-based clearance path.

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 20
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K053008.
ENDOGATER AVANTAGE CO2 INSUFFLATOR
K113310 · Byrne Medical, Inc. · Jun 2012
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
K111648 · Bracco Diagnostic, Inc. · Nov 2011
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
K063786 · Olympus Medical Systems Corporation · Mar 2007
PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
K030854 · E-Z-Em, Inc. · Apr 2003
PROTOCO2L INSUFFLATOR MODEL 6400
K013219 · E-Z-Em, Inc. · Feb 2002
E-Z-FLATE
K930581 · E-Z-Em, Inc. · Jul 1994