Cleared Traditional

K945970 - INSUFFLATOR FILTER TUBING SET

K945970 is an FDA 510(k) clearance for INSUFFLATOR FILTER TUBING SET, manufactured by Xylog Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FCX cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K945970 · Xylog Corp. · Gastroenterology & Urology device
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Dec 1994
Decision
7d
Days
Class 2
Risk

K945970 is an FDA 510(k) clearance for the INSUFFLATOR FILTER TUBING SET. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by Xylog Corp. (Hackensack, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 7 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xylog Corp. devices

FDA 510(k) Submission Details - K945970

510(k) Number K945970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1994
Decision Date December 15, 1994
Days to Decision 7 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 130d · This submission: 7d
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 15
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K945970.
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
PROTOCO2L INSUFFLATOR MODEL 6400
K013219 · E-Z-Em, Inc. · Feb 2002
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