Cleared Traditional

K803148 - CONPHAR PERCUSSION HAMMER(TAYLOR) (FDA 510(k) Clearance)

Class I Neurology device.

K803148 · Conphar, Inc. · Neurology device
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Jan 1981
Decision
27d
Days
Class 1
Risk

K803148 is an FDA 510(k) clearance for the CONPHAR PERCUSSION HAMMER(TAYLOR). Classified as Percussor (product code GWZ), Class I - General Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 8, 1981 after a review of 27 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 Conphar, Inc. devices

Submission Details

510(k) Number K803148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1980
Decision Date January 08, 1981
Days to Decision 27 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 148d · This submission: 27d
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.