Cleared Traditional

K936039 - ALGO-2 NEWBORN HEARING SCREENER

K936039 is an FDA 510(k) clearance for ALGO-2 NEWBORN HEARING SCREENER, manufactured by Natus Medical, Inc.. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K936039 · Natus Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
381d
Days
Class 2
Risk

K936039 is an FDA 510(k) clearance for the ALGO-2 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 January 5, 1995 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K936039

510(k) Number K936039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date January 05, 1995
Days to Decision 381 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 149d · This submission: 381d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K936039.
CHARTR EP
K960097 · Ics Medical Corp. · Feb 1997
TECA PREMIERE
K953732 · Medelec , Ltd. · Oct 1995
CLARITY SYSTEM II
K952080 · Sonamed Corp. · Sep 1995
SMART-SCREENER (AUDITORY)
K925648 · Intelligent Hearing Systems · May 1993
MODEL 330 SCREENING AUDIO METER, MODIFIED
K926574 · Virtual Corp. · Mar 1993
DANTEC COUNTERPOINT MK2(TM)
K913957 · Dantec Medical, Inc. · Jan 1992
K936039 · ALGO-2 NEWBORN HEARING SCREENER
Download PDF Natus Medical, Inc.