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Synap-I Infant Sensory Assessment Unit

by Infant Hearing Assessment Foundation

510(k) K810138

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810138 Date3 Apr 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GWJ
Device Class
Class II
Regulation
21 CFR Part 882.1900
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Synap-I Infant Sensory Assessment Unit is an auditory evoked response stimulator. It is designed to function as a medical device for sensory assessment in infants.

This device is classified as a Class 2 medical device under regulation number 882.1900. It has received FDA 510(k) clearance as a traditional submission.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Synap-I Infant Sensory Assessment Unit?

    The Synap-I is an auditory evoked response stimulator. It is specifically designed to function as a medical device for performing sensory assessments in infants.

  • How is the Synap-I classified for regulatory purposes?

    The device is classified as a Class 2 medical device under regulation number 882.1900. It has received FDA 510(k) clearance as a traditional submission.

  • Which medical specialty oversees this device?

    The Synap-I falls under the Neurology medical specialty, as indicated by the advisory committee classification for this device type.