Cleared Traditional

K935059 - INSUFFLATION TUBING SET

K935059 is an FDA 510(k) clearance for INSUFFLATION TUBING SET, manufactured by Phx Technologies Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FCX cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K935059 · Phx Technologies Corp. · Gastroenterology & Urology device
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Dec 1993
Decision
62d
Days
Class 2
Risk

K935059 is an FDA 510(k) clearance for the INSUFFLATION TUBING SET, PHX500-082. Classified as Insufflator, Automatic Carbon-dioxide For Endoscope (product code FCX), Class II - Special Controls.

Submitted by Phx Technologies Corp. (Lewisville, US). The FDA issued a Cleared decision on December 22, 1993 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 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 Phx Technologies Corp. devices

FDA 510(k) Submission Details - K935059

510(k) Number K935059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1993
Decision Date December 22, 1993
Days to Decision 62 days
Submission Type Traditional
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
68d faster than avg
Panel avg: 130d · This submission: 62d
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 14
Devices cleared under the same product code (FCX) and FDA review panel - the closest regulatory comparables to K935059.
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
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