Cleared Traditional

K810138 - SYNAP-I INFANT SENSORY ASSESSMENT UNIT

K810138 is an FDA 510(k) clearance for SYNAP-I INFANT SENSORY ASSESSMENT UNIT, manufactured by Infant Hearing Assessment Foundation. The device is a Class 2 Neurology device with product code GWJ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K810138 · Infant Hearing Assessment Foundation · Neurology device
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Apr 1981
Decision
72d
Days
Class 2
Risk

K810138 is an FDA 510(k) clearance for the SYNAP-I INFANT SENSORY ASSESSMENT UNIT. Classified as Stimulator, Auditory, Evoked Response (product code GWJ), Class II - Special Controls.

Submitted by Infant Hearing Assessment Foundation (Mchenry, US). The FDA issued a Cleared decision on April 3, 1981 after a review of 72 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 Infant Hearing Assessment Foundation devices

FDA 510(k) Submission Details - K810138

510(k) Number K810138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1981
Decision Date April 03, 1981
Days to Decision 72 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 148d · This submission: 72d
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 48
Devices cleared under the same product code (GWJ) and FDA review panel - the closest regulatory comparables to K810138.
MULTI-SIGNAL AUDITORY STIMULATOR SM700
K830579 · Nicolet Biomedical Instruments · Mar 1983
AUDIOMETERS (VARIOUS MODELS)
K822177 · Kelleher Corp. · Aug 1982
TECA VISUAL/AUDIO STIMULATOR MODEL CS-2
K813009 · Teca, Inc. · Dec 1981
ELECTRIC RESPONSE AUDIOMETER
K780540 · Life-Tech Instruments, Inc. · Apr 1978
SYS. FOR REC. BSER RESPONSES
K770268 · Life-Tech Instruments, Inc. · Feb 1977