Cleared Special

K013137 - ALGO 3 NEWBORN HEARING SCREENER

K013137 is an FDA 510(k) clearance for ALGO 3 NEWBORN HEARING SCREENER, manufactured by Natus Medical, Inc.. The device is a Class 2 Neurology device with product code GWJ cleared through the Special 510(k) pathway after a 27-day FDA review.

K013137 · Natus Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
27d
Days
Class 2
Risk

K013137 is an FDA 510(k) clearance for the ALGO 3 NEWBORN HEARING SCREENER. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Natus Medical, Inc. (San Carlos, US). The FDA issued a Cleared decision on October 16, 2001 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1900 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K013137

510(k) Number K013137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2001
Decision Date October 16, 2001
Days to Decision 27 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 149d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 Peers - GWJ Stimulator, Auditory, Evoked Response

All 75
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K013137.
BIO-LOGIC ABAER CUB
K021215 · Bio-Logic Systems Corp. · May 2002
SABRE COMPAC
K011842 · Sle Limited · Jan 2002
AURIS AEP
K012415 · Synapsys, Inc. · Dec 2001
MB 11
K011746 · Maico Diagnostic GmbH · Aug 2001
ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
K002985 · Ics Medical Corp. · Dec 2000
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149 · Bio-Logic Systems Corp. · Dec 1999
K013137 · ALGO 3 NEWBORN HEARING SCREENER
Download PDF FDA Summary Natus Medical, Inc.