Cleared Traditional

K912855 - HAZEL

K912855 is an FDA 510(k) clearance for HAZEL, 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 70-day FDA review.

K912855 · Kinetic Concepts, Inc. · Physical Medicine device
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Sep 1991
Decision
70d
Days
Class 2
Risk

K912855 is an FDA 510(k) clearance for the HAZEL. 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 September 6, 1991 after a review of 70 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 - K912855

510(k) Number K912855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1991
Decision Date September 06, 1991
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 K912855.
HAZEL II
K921768 · Kinetic Concepts, Inc. · Apr 1992
TURBO
K912854 · Kinetic Concepts, Inc. · Dec 1991
CLA-1400 SYSTEM
K914851 · Gaymar Industries, Inc. · Nov 1991
MODIFIED ROTATION AIR FLUIDIZED BED/THE THERAPULSE
K875321 · Kinetic Concepts, Inc. · Jan 1988
ROTATION AIR FLUIDIZED BED/DELTA
K864232 · Kinetic Concepts, Inc. · Dec 1986