Cleared Traditional

K972486 - PRESSUREGUARD IV

K972486 is the FDA 510(k) clearance for PRESSUREGUARD IV by Span-America Medical Systems, Inc.. It is a Class 2 Physical Medicine device (product code IKZ) cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K972486 · Span-America Medical Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
233d
Days
Class 2
Risk

K972486 is an FDA 510(k) clearance for the PRESSUREGUARD IV. Classified as Bed, Patient Rotation, Powered (product code IKZ), Class II - Special Controls.

Submitted by Span-America Medical Systems, Inc. (Greenville, US). The FDA issued a Cleared decision on February 20, 1998 after a review of 233 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5225 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Span-America Medical Systems, Inc. devices

Submission Details

510(k) Number K972486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1997
Decision Date February 20, 1998
Days to Decision 233 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 115d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKZ Bed, Patient Rotation, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5225
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IKZ Bed, Patient Rotation, Powered

All 7
Devices cleared under the same product code (IKZ) and FDA review panel - the closest regulatory comparables to K972486.
RUMORS DYNAMIC AIR THERAPY UNIT
K972111 · Hill-Rom, Inc. · Feb 1998
PULMONEX DYNAMIC AIR THERAPY UNIT
K950756 · Hill-Rom, Inc. · May 1995
MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY
K950681 · Invacare Corp. · May 1995
KUDO (POWERED ROTATION BED)
K905390 · Kinetic Concepts, Inc. · Jan 1991
EGERTON TURNING & TILTING BED
K834563 · Kinetic Concepts, Inc. · Jan 1984
ROTO REST KINETIC TREATMENT TABLE PEDIA
K822402 · Kinetic Concepts, Inc. · Oct 1982