Cleared Traditional

K925052 - QA PRESSURE MEASUREMENT SYSTEM

K925052 is an FDA 510(k) clearance for QA PRESSURE MEASUREMENT SYSTEM, manufactured by Gabel Medical Instruments, Ltd.. The device is a Class 1 Physical Medicine device with product code JFC cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K925052 · Gabel Medical Instruments, Ltd. · Physical Medicine device
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Mar 1993
Decision
154d
Days
Class 1
Risk

K925052 is an FDA 510(k) clearance for the QA PRESSURE MEASUREMENT SYSTEM. Classified as System, Pressure Measurement, Intermittent (product code JFC), Class I - General Controls.

Submitted by Gabel Medical Instruments, Ltd. (Victoria, Prov. B.C., CA). The FDA issued a Cleared decision on March 9, 1993 after a review of 154 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1600 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Gabel Medical Instruments, Ltd. devices

FDA 510(k) Submission Details - K925052

510(k) Number K925052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1992
Decision Date March 09, 1993
Days to Decision 154 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

JFC Device Classification - Class 1, General Controls

Product Code JFC System, Pressure Measurement, Intermittent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1600
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.