Cleared Abbreviated

K013219 - PROTOCO2L INSUFFLATOR MODEL 6400

K013219 is the FDA 510(k) clearance for PROTOCO2L INSUFFLATOR MODEL 6400 by E-Z-Em, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FCX) cleared through the Abbreviated 510(k) pathway after a 146-day FDA review.

K013219 · E-Z-Em, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
146d
Days
Class 2
Risk

K013219 is an FDA 510(k) clearance for the PROTOCO2L INSUFFLATOR 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 February 19, 2002 after a review of 146 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. 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

Submission Details

510(k) Number K013219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2001
Decision Date February 19, 2002
Days to Decision 146 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
16d slower than avg
Panel avg: 130d · This submission: 146d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 13
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K013219.
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
E-Z-FLATE
K930581 · E-Z-Em, Inc. · Jul 1994
INSUFFLATION TUBING SET, PHX500-082
K935059 · Phx Technologies Corp. · Dec 1993
MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
K910716 · Richard Wolf Medical Instruments Corp. · Apr 1991