Cleared Special

K030823 - ALGO 3I NEWBORN HEARING SCREENER

K030823 is the FDA 510(k) clearance for ALGO 3I NEWBORN HEARING SCREENER by Natus Medical, Inc.. It is a Class 2 Neurology device (product code GWJ) cleared through the Special 510(k) pathway after a 26-day FDA review.

K030823 · Natus Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
26d
Days
Class 2
Risk

K030823 is an FDA 510(k) clearance for the ALGO 3I 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 April 9, 2003 after a review of 26 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.

View all Natus Medical, Inc. devices

Submission Details

510(k) Number K030823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2003
Decision Date April 09, 2003
Days to Decision 26 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 148d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 17
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K030823.
BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
K073626 · Bio-Logic Systems Corp. · Feb 2008
STACKED ABR FOR NAVIGATOR PRO
K030907 · Bio-Logic Systems Corp. · May 2003
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
K031009 · Bio-Logic Systems Corp. · Apr 2003
BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM
K021895 · Bio-Logic Systems Corp. · Jul 2002
BIO-LOGIC ABAER CUB
K021215 · Bio-Logic Systems Corp. · May 2002
MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.
K994149 · Bio-Logic Systems Corp. · Dec 1999