Cleared Traditional

K940132 - PODIATRIC MATERIAL

K940132 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 269-day FDA review.

K940132 · Crown Delta Corp. · Physical Medicine device
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Sep 1994
Decision
269d
Days
Class 1
Risk

K940132 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. (Yorktown Heights, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 269 days - an extended review cycle.

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 - K940132

510(k) Number K940132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date September 29, 1994
Days to Decision 269 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
154d slower than avg
Panel avg: 115d · This submission: 269d
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.