Cleared Traditional

K970081 - SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM

K970081 is an FDA 510(k) clearance for SUPER AIR 9000 ALTERNATING AIR FLOATATI..., manufactured by Cathay Consolidated, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K970081 · Cathay Consolidated, Inc. · General Hospital
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Nov 1997
Decision
302d
Days
Class 2
Risk

K970081 is an FDA 510(k) clearance for the SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Cathay Consolidated, Inc. (Taipei, TW). The FDA issued a Cleared decision on November 7, 1997 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5550 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Cathay Consolidated, Inc. devices

FDA 510(k) Submission Details - K970081

510(k) Number K970081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1997
Decision Date November 07, 1997
Days to Decision 302 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 129d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNM Device Classification - Class 2, Special Controls

Product Code FNM Mattress, Air Flotation, Alternating Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5550
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 General Hospital devices follow this clearance model.

Regulatory Peers - FNM Mattress, Air Flotation, Alternating Pressure

All 40
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K970081.
MIGHTY AIR
K974319 · Wheelchairs of Kansas · Jan 1998
PHYSIO/1000
K974070 · Physio Designs, Inc. · Jan 1998
SIMPULSE
K972549 · Kinetic Concepts, Inc. · Nov 1997
BARIAIR
K955243 · Kinetic Concepts, Inc. · Oct 1997
KT AIR BED
K970468 · Kinetic Concepts, Inc. · Sep 1997
RID-DECUBE II
K965207 · Skin Care Management, Inc. · Aug 1997