Cleared Traditional

K961129 - AREMA II

K961129 is an FDA 510(k) clearance for AREMA II, manufactured by Mellen Air Mfg., Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K961129 · Mellen Air Mfg., Inc. · General Hospital
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Apr 1996
Decision
27d
Days
Class 2
Risk

K961129 is an FDA 510(k) clearance for the AREMA II. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Mellen Air Mfg., Inc. (Long Beach, US). The FDA issued a Cleared decision on April 17, 1996 after a review of 27 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 Mellen Air Mfg., Inc. devices

FDA 510(k) Submission Details - K961129

510(k) Number K961129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1996
Decision Date April 17, 1996
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 K961129.
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ALTACARE
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THE AIRCEL SYSTEM
K954593 · Marcon Group, Inc. · Feb 1996