Cleared Traditional

K781363 - CAST SHOE

K781363 is an FDA 510(k) clearance for CAST SHOE, manufactured by Cutler Biomedical. The device is a Class 1 Physical Medicine device with product code IPG cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K781363 · Cutler Biomedical · Physical Medicine device
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Aug 1978
Decision
7d
Days
Class 1
Risk

K781363 is an FDA 510(k) clearance for the CAST SHOE. Classified as Shoe, Cast (product code IPG), Class I - General Controls.

Submitted by Cutler Biomedical (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3025 - 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.

FDA 510(k) Submission Details - K781363

510(k) Number K781363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1978
Decision Date August 14, 1978
Days to Decision 7 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
109d faster than avg
Panel avg: 116d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

IPG Device Classification - Class 1, General Controls

Product Code IPG Shoe, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

K781363 · CAST SHOE
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