Cleared Traditional

K820612 - TENSOPLAST SKIN TRACTION KIT (FDA 510(k) Clearance)

Class I Neurology device.

K820612 · Smith & Nephew, Inc. · Neurology device
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Mar 1982
Decision
23d
Days
Class 1
Risk

K820612 is an FDA 510(k) clearance for the TENSOPLAST SKIN TRACTION KIT. Classified as Apparatus, Traction, Non-powered (product code HST), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1982 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.5850 - the FDA neurology 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K820612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1982
Decision Date March 31, 1982
Days to Decision 23 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 148d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HST Apparatus, Traction, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5850
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.