Cleared Traditional

K953503 - PRESSUREGUARD IV

K953503 is an FDA 510(k) clearance for PRESSUREGUARD IV, manufactured by Span-America Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K953503 · Span-America Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
90d
Days
Class 2
Risk

K953503 is an FDA 510(k) clearance for the PRESSUREGUARD IV. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on October 24, 1995 after a review of 90 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.

FDA 510(k) Submission Details - K953503

510(k) Number K953503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1995
Decision Date October 24, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 101
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K953503.
THE AIRCEL SYSTEM
K954593 · Marcon Group, Inc. · Feb 1996
PRESSURE GUARD ALTERNATING PRESSURE MATTRESS
K954766 · Span-America Medical Systems, Inc. · Jan 1996
CARDIO-SYSTEMS PRO-OP
K953196 · Ch Administration, Inc. · Nov 1995
ALTADYNE
K953675 · Lumex, Inc. · Sep 1995
PLEXUS/3000 (P/3000), PLEXUS/3500 (P/3500)
K952610 · Plexus Medical · Sep 1995
AMERIMED AS110
K953069 · Amerimed Systems L.C. · Aug 1995
K953503 · PRESSUREGUARD IV
Download PDF FDA Summary Span-America Medical …