Cleared Traditional

K780391 - PODIATRIC MATERIAL

K780391 is an FDA 510(k) clearance for PODIATRIC MATERIAL, manufactured by Crown Delta Corp.. The device is a Class 1 Physical Medicine device with product code MNE cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K780391 · Crown Delta Corp. · Physical Medicine device
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Jun 1978
Decision
96d
Days
Class 1
Risk

K780391 is an FDA 510(k) clearance for the PODIATRIC MATERIAL. Classified as Orthosis, Moldable, Supportive, Skin Protective (product code MNE), Class I - General Controls.

Submitted by Crown Delta Corp. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1978 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Crown Delta Corp. devices

FDA 510(k) Submission Details - K780391

510(k) Number K780391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1978
Decision Date June 14, 1978
Days to Decision 96 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
19d faster than avg
Panel avg: 115d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

MNE Device Classification - Class 1, General Controls

Product Code MNE Orthosis, Moldable, Supportive, Skin Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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.