Cleared Traditional

K852716 - TAYLOR PERCUSSION HAMMER SS 410 OR 420 (FDA 510(k) Clearance)

Class I Neurology device.

K852716 · The Huxley Instrument Corp. · Neurology device
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Jul 1985
Decision
30d
Days
Class 1
Risk

K852716 is an FDA 510(k) clearance for the TAYLOR PERCUSSION HAMMER SS 410 OR 420. Classified as Percussor (product code GWZ), Class I - General Controls.

Submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on July 26, 1985 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1700 - 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 The Huxley Instrument Corp. devices

Submission Details

510(k) Number K852716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1985
Decision Date July 26, 1985
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GWZ Percussor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1700
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.