Cleared Traditional

K953069 - AMERIMED AS110

K953069 is an FDA 510(k) clearance for AMERIMED AS110, manufactured by Amerimed Systems L.C.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K953069 · Amerimed Systems L.C. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
62d
Days
Class 2
Risk

K953069 is an FDA 510(k) clearance for the AMERIMED AS110. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Amerimed Systems L.C. (Desoto, US). The FDA issued a Cleared decision on August 31, 1995 after a review of 62 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 Amerimed Systems L.C. devices

FDA 510(k) Submission Details - K953069

510(k) Number K953069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1995
Decision Date August 31, 1995
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
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 52
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K953069.
THE AIRCEL SYSTEM
K954593 · Marcon Group, Inc. · Feb 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
PRESSUREGUARD IV
K951112 · Span-America Medical Systems, Inc. · Jun 1995
TRIADYNE
K944094 · Kinetic Concepts, Inc. · May 1995