Cleared Traditional

K954593 - THE AIRCEL SYSTEM

K954593 is an FDA 510(k) clearance for THE AIRCEL SYSTEM, manufactured by Marcon Group, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K954593 · Marcon Group, Inc. · General Hospital
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Feb 1996
Decision
126d
Days
Class 2
Risk

K954593 is an FDA 510(k) clearance for the THE AIRCEL SYSTEM. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Marcon Group, Inc. (Washington, US). The FDA issued a Cleared decision on February 6, 1996 after a review of 126 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Marcon Group, Inc. devices

FDA 510(k) Submission Details - K954593

510(k) Number K954593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1995
Decision Date February 06, 1996
Days to Decision 126 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
3d faster than avg
Panel avg: 129d · This submission: 126d
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 51
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K954593.
AREMA II
K961129 · Mellen Air Mfg., Inc. · Apr 1996
ALTACARE
K955874 · Asf Industries, Inc. · Mar 1996
MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
K960411 · Invacare Corp. · Mar 1996
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
K954766 · Span-America Medical Systems, Inc. · Jan 1996
PRESSUREGUARD IV
K953503 · Span-America Medical Systems, Inc. · Oct 1995
BAZOOKA SYSTEM
K951469 · Innovative Medical Systems, Inc. · Jun 1995