Cleared Traditional

K930508 - HIFLO FILTERED INSUFFLATION TUBING

K930508 is an FDA 510(k) clearance for HIFLO FILTERED INSUFFLATION TUBING, manufactured by W. J. Medical Instruments, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FCX cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K930508 · W. J. Medical Instruments, Inc. · Gastroenterology & Urology device
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Jun 1993
Decision
144d
Days
Class 2
Risk

K930508 is an FDA 510(k) clearance for the HIFLO FILTERED INSUFFLATION TUBING. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by W. J. Medical Instruments, Inc. (Newbury Park, US). The FDA issued a Cleared decision on June 25, 1993 after a review of 144 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all W. J. Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K930508

510(k) Number K930508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date June 25, 1993
Days to Decision 144 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 130d · This submission: 144d
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 K930508.
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
OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR
K881004 · Keymed, Inc. · May 1988