Cleared Traditional

K933964 - THE CRADLE

K933964 is an FDA 510(k) clearance for THE CRADLE, manufactured by The Primal Energy Research Foundation. The device is a Class 2 Physical Medicine device with product code IKZ cleared through the Traditional 510(k) pathway after a 413-day FDA review.

K933964 · The Primal Energy Research Foundation · Physical Medicine device
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Oct 1994
Decision
413d
Days
Class 2
Risk

K933964 is an FDA 510(k) clearance for the THE CRADLE. Classified as Bed, Patient Rotation, Powered (product code IKZ), Class II - Special Controls.

Submitted by The Primal Energy Research Foundation (Houston, US). The FDA issued a Cleared decision on October 3, 1994 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all The Primal Energy Research Foundation devices

FDA 510(k) Submission Details - K933964

510(k) Number K933964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1993
Decision Date October 03, 1994
Days to Decision 413 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
298d slower than avg
Panel avg: 115d · This submission: 413d
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 K933964.
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