Cleared Traditional

K950756 - PULMONEX DYNAMIC AIR THERAPY UNIT (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950756 · Hill-Rom, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
102d
Days
Class 2
Risk

K950756 is an FDA 510(k) clearance for the PULMONEX DYNAMIC AIR THERAPY UNIT. Classified as Bed, Patient Rotation, Powered (product code IKZ), Class II - Special Controls.

Submitted by Hill-Rom, Inc. (Charleston, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 102 days - within the typical 510(k) review window.

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 Hill-Rom, Inc. devices

Submission Details

510(k) Number K950756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1995
Decision Date May 30, 1995
Days to Decision 102 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
13d faster than avg
Panel avg: 115d · This submission: 102d
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.