Cleared Traditional

K822402 - ROTO REST KINETIC TREATMENT TABLE PEDIA

K822402 is an FDA 510(k) clearance for ROTO REST KINETIC TREATMENT TABLE PEDIA, manufactured by Kinetic Concepts, Inc.. The device is a Class 2 Physical Medicine device with product code IKZ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K822402 · Kinetic Concepts, Inc. · Physical Medicine device
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Oct 1982
Decision
73d
Days
Class 2
Risk

K822402 is an FDA 510(k) clearance for the ROTO REST KINETIC TREATMENT TABLE PEDIA. Classified as Bed, Patient Rotation, Powered (product code IKZ), Class II - Special Controls.

Submitted by Kinetic Concepts, Inc. (Walker, US). The FDA issued a Cleared decision on October 22, 1982 after a review of 73 days - a notably fast clearance 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: 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 Kinetic Concepts, Inc. devices

FDA 510(k) Submission Details - K822402

510(k) Number K822402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1982
Decision Date October 22, 1982
Days to Decision 73 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 115d · This submission: 73d
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.