510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K810138Substantially Equivalent

Synap-I Infant Sensory Assessment Unit

Infant Hearing Assessment Foundation, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810138 is the FDA 510(k) clearance record for SYNAP-I INFANT SENSORY ASSESSMENT UNIT, a class II device, cleared for Infant Hearing Assessment Foundation on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list one 510(k) clearance for Infant Hearing Assessment Foundation. As of , FDA records show no recalls naming K810138.

Clearance record

Decision date
Received
(72 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Infant Hearing Assessment Foundation 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GWJ

Trailing 12 months

FDA records hold no clearances under product code GWJ in the trailing twelve months.

FDA records show no clearances under product code GWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GWJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260