Cleared Traditional

K122067 - TYPE 1077 ACCUSCREEN

K122067 is an FDA 510(k) clearance for TYPE 1077 ACCUSCREEN, manufactured by Gn Otometrics. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K122067 · Gn Otometrics · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
73d
Days
Class 2
Risk

K122067 is an FDA 510(k) clearance for the TYPE 1077 ACCUSCREEN. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Gn Otometrics (Taastrup, DK). The FDA issued a Cleared decision on September 27, 2012 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - 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 Gn Otometrics devices

FDA 510(k) Submission Details - K122067

510(k) Number K122067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2012
Decision Date September 27, 2012
Days to Decision 73 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 148d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GWJ Device Classification - Class 2, Special Controls

Product Code GWJ Stimulator, Auditory, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1900
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.

Regulatory Consultant

Intertek Testing Services
PAULA WILKERSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GWJ Stimulator, Auditory, Evoked Response

All 48
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K122067.
MADSEN ACCUSCREEN TYPE 1077
K132957 · Gn Otometrics · Feb 2014
EARPROBE
K131141 · Path Medical GmbH · Jun 2013
HEARLAB ACA
K123701 · Frye Electronics, Inc. · Apr 2013
CIRCUMAURAL ADHESIVE REPLACEMENT
K111555 · R & D Medical Products, Inc. · Jul 2011
TITAN
K103760 · Interacoustics A/S · May 2011
EARPROBE
K100661 · Path Medical GmbH · Jul 2010