Cleared Traditional

K812951 - RION AUDIOMETER AA-67

K812951 is the FDA 510(k) clearance for RION AUDIOMETER AA-67 by Rion Acoustic Instruments, Inc.. It is a Class 2 Neurology device (product code GWO) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K812951 · Rion Acoustic Instruments, Inc. · Neurology device
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Nov 1981
Decision
16d
Days
Class 2
Risk

K812951 is an FDA 510(k) clearance for the RION AUDIOMETER AA-67. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Rion Acoustic Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - 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 Rion Acoustic Instruments, Inc. devices

Submission Details

510(k) Number K812951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1981
Decision Date November 06, 1981
Days to Decision 16 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
132d faster than avg
Panel avg: 148d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWO Plate, Cranioplasty, Preformed, Alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.