Cleared Traditional

K832991 - HYPAL ADHESIVE TAPE (FDA 510(k) Clearance)

Class I Neurology device.

K832991 · Smith & Nephew, Inc. · Neurology device
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Jan 1984
Decision
150d
Days
Class 1
Risk

K832991 is an FDA 510(k) clearance for the HYPAL ADHESIVE TAPE. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Smith & Nephew, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 150 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K832991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1983
Decision Date January 30, 1984
Days to Decision 150 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 148d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
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.