Cleared Traditional

K051256 - SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC (FDA 510(k) Clearance)

Class I Physical Medicine device.

K051256 · Noble Fiber Technologies, Inc. · Physical Medicine device
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Jul 2005
Decision
66d
Days
Class 1
Risk

K051256 is an FDA 510(k) clearance for the SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC. Classified as Component, External, Limb, Ankle/foot (product code ISH), Class I - General Controls.

Submitted by Noble Fiber Technologies, Inc. (Clarks Summit, US). The FDA issued a Cleared decision on July 21, 2005 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3420 - 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.

View all Noble Fiber Technologies, Inc. devices

Submission Details

510(k) Number K051256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2005
Decision Date July 21, 2005
Days to Decision 66 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 115d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ISH Component, External, Limb, Ankle/foot
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3420
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.