Cleared Traditional

ALGO-2 NEWBORN HEARING SCREENER (K936039) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K936039 · Natus Medical, Inc. · Neurology device
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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.

View all Natus Medical, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 148d · This submission: 381d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 75
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K936039.
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