Cleared Traditional

K840617 - MASTERFOOT CAST HEEL (FDA 510(k) Clearance)

Class I Orthopedic device.

K840617 · Seton Products, Inc. · Orthopedic device
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Mar 1984
Decision
39d
Days
Class 1
Risk

K840617 is an FDA 510(k) clearance for the MASTERFOOT CAST HEEL. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Seton Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5940 - the FDA orthopedic device regulatory 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 Seton Products, Inc. devices

Submission Details

510(k) Number K840617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1984
Decision Date March 23, 1984
Days to Decision 39 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 122d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LGF Component, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5940
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.