Cleared Traditional

K972153 - ALTERNATING PRESSURE AIR FLOTATION MATTRESS

K972153 is an FDA 510(k) clearance for ALTERNATING PRESSURE AIR FLOTATION MATTRESS, manufactured by Decubiti Concepts, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K972153 · Decubiti Concepts, Inc. · General Hospital
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Jul 1997
Decision
52d
Days
Class 2
Risk

K972153 is an FDA 510(k) clearance for the ALTERNATING PRESSURE AIR FLOTATION MATTRESS. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Decubiti Concepts, Inc. (Mt Pleasant, US). The FDA issued a Cleared decision on July 31, 1997 after a review of 52 days - a notably fast clearance cycle.

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: 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 Decubiti Concepts, Inc. devices

FDA 510(k) Submission Details - K972153

510(k) Number K972153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1997
Decision Date July 31, 1997
Days to Decision 52 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
77d faster than avg
Panel avg: 129d · This submission: 52d
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 K972153.
BARIAIR
K955243 · Kinetic Concepts, Inc. · Oct 1997
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MODIFIED PEDIKAIR
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REST MATTRESS
K971568 · Rest Mattress · Jul 1997
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM
K970362 · Apex Metal, Inc. · May 1997