Cleared Traditional

K934689 - LOW AIR LOSS MATTRESS, MODIFICATION

K934689 is an FDA 510(k) clearance for LOW AIR LOSS MATTRESS, manufactured by Cardio Systems, Inc.. The device is a Class 2 Physical Medicine device with product code INX cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K934689 · Cardio Systems, Inc. · Physical Medicine device
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Feb 1994
Decision
163d
Days
Class 2
Risk

K934689 is an FDA 510(k) clearance for the LOW AIR LOSS MATTRESS, MODIFICATION. Classified as Bed, Air Fluidized (product code INX), Class II - Special Controls.

Submitted by Cardio Systems, Inc. (Dallas, US). The FDA issued a Cleared decision on February 2, 1994 after a review of 163 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5160 - 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 Cardio Systems, Inc. devices

FDA 510(k) Submission Details - K934689

510(k) Number K934689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1993
Decision Date February 02, 1994
Days to Decision 163 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
48d slower than avg
Panel avg: 115d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INX Device Classification - Class 2, Special Controls

Product Code INX Bed, Air Fluidized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5160
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 - INX Bed, Air Fluidized

Devices cleared under the same product code (INX) and FDA review panel - the closest regulatory comparables to K934689.
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