Cleared Traditional

K925694 - MICROAIR PUP

K925694 is an FDA 510(k) clearance for MICROAIR PUP, manufactured by Gsi Medical Systems. The device is a Class 2 Physical Medicine device with product code IOQ cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K925694 · Gsi Medical Systems · Physical Medicine device
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Mar 1993
Decision
132d
Days
Class 2
Risk

K925694 is an FDA 510(k) clearance for the MICROAIR PUP. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Gsi Medical Systems (Carmel, US). The FDA issued a Cleared decision on March 24, 1993 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5170 - 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 Gsi Medical Systems devices

FDA 510(k) Submission Details - K925694

510(k) Number K925694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date March 24, 1993
Days to Decision 132 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
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IOQ Device Classification - Class 2, Special Controls

Product Code IOQ Bed, Flotation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5170
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IOQ Bed, Flotation Therapy, Powered

All 17
Devices cleared under the same product code (IOQ) and FDA review panel - the closest regulatory comparables to K925694.
FLEXICAIR EXLIPSE
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K912854 · Kinetic Concepts, Inc. · Dec 1991
CLA-1400 SYSTEM
K914851 · Gaymar Industries, Inc. · Nov 1991