Cleared Traditional

ALGESIOMETER (K801907) - FDA 510(k) Clearance

Class I Neurology device.

K801907 · Rowan Products, Inc. · Neurology device
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Sep 1980
Decision
36d
Days
Class 1
Risk

K801907 is an FDA 510(k) clearance for the ALGESIOMETER. Classified as Esthesiometer (product code GXB), Class I - General Controls.

Submitted by Rowan Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1500 - 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: 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 Rowan Products, Inc. devices

Submission Details

510(k) Number K801907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1980
Decision Date September 16, 1980
Days to Decision 36 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 148d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GXB Esthesiometer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.1500
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.