Cleared Traditional

K923710 - OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED

K923710 is an FDA 510(k) clearance for OSCILLAIR 3000 LOW AIR LOSS KINETIC THE..., manufactured by Progressive Medical Technology, Inc.. The device is a Class 2 Physical Medicine device with product code IKZ cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K923710 · Progressive Medical Technology, Inc. · Physical Medicine device
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Mar 1993
Decision
238d
Days
Class 2
Risk

K923710 is an FDA 510(k) clearance for the OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED. Classified as Bed, Patient Rotation, Powered (product code IKZ), Class II - Special Controls.

Submitted by Progressive Medical Technology, Inc. (Lansing, US). The FDA issued a Cleared decision on March 22, 1993 after a review of 238 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 Progressive Medical Technology, Inc. devices

FDA 510(k) Submission Details - K923710

510(k) Number K923710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1992
Decision Date March 22, 1993
Days to Decision 238 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 115d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKZ Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (IKZ) and FDA review panel - the closest regulatory comparables to K923710.
THE FREEDOM BED
K954671 · Probed Medical Technologies, Inc. · Apr 1996
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
EMERSON MOTION BED 6-MS & 6-ME
K842604 · J. H. Emerson Co. · Jul 1984
EGERTON TURNING & TILTING BED
K834563 · Kinetic Concepts, Inc. · Jan 1984