Cleared Traditional

K921768 - HAZEL II

K921768 is an FDA 510(k) clearance for HAZEL II, manufactured by Kinetic Concepts, Inc.. The device is a Class 2 Physical Medicine device with product code IOQ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K921768 · Kinetic Concepts, Inc. · Physical Medicine device
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Apr 1992
Decision
15d
Days
Class 2
Risk

K921768 is an FDA 510(k) clearance for the HAZEL II. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 29, 1992 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5170 - 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 - K921768

510(k) Number K921768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1992
Decision Date April 29, 1992
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IOQ Device Classification - Class 2, Special Controls

Product Code IOQ Bed, Flotation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5170
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 - IOQ Bed, Flotation Therapy, Powered

All 11
Devices cleared under the same product code (IOQ) and FDA review panel - the closest regulatory comparables to K921768.
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