Cleared Traditional

K960620 - PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM

K960620 is an FDA 510(k) clearance for PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM, 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 72-day FDA review.

K960620 · Span-America Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
72d
Days
Class 2
Risk

K960620 is an FDA 510(k) clearance for the PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM. 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 April 25, 1996 after a review of 72 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 Span-America Medical Systems, Inc. devices

FDA 510(k) Submission Details - K960620

510(k) Number K960620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1996
Decision Date April 25, 1996
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
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 K960620.
SPR PLUS II OVERLAY SYSTEM (CL250/CL212
K961854 · Gaymar Industries, Inc. · Aug 1996
AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
K962123 · Lumex, Inc. · Jul 1996
POWERED LOW AIR LOSS MATTRESS SYSTEM
K961159 · Span-America Medical Systems, Inc. · Jun 1996
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