Cleared Traditional

K820612 - TENSOPLAST SKIN TRACTION KIT

K820612 is an FDA 510(k) clearance for TENSOPLAST SKIN TRACTION KIT, manufactured by Smith & Nephew, Inc.. The device is a Class 1 Neurology device with product code HST cleared through the Traditional 510(k) pathway after a 23-day FDA review.

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.

FDA 510(k) Submission Details - K820612

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 149d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

HST Device Classification - Class 1, General Controls

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.

Regulatory Peers - HST Apparatus, Traction, Non-powered

All 37
Devices cleared under the same product code (HST) and FDA review panel - the closest regulatory comparables to K820612.
FOREARM REDUCTION UNIT
K823392 · Orthopedic Systems, Inc. · Nov 1982
SENATEK
K822993 · American Health Tech., Inc. · Oct 1982
CERVITRAC TRACTION FRAME & CORD
K821522 · George W. Cottrell · Jun 1982
NECKTRAC
K813017 · Lossing Orthopedic, Inc. · Nov 1981
ZEE TRACTION SPLINT
K813016 · Zee Medical Products Co., Inc. · Nov 1981
EXTENSIONS-LUSATZTISCH
K812779 · The Telos Co. · Oct 1981
K820612 · TENSOPLAST SKIN TRACTION KIT
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