510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202927Substantially Equivalent

Eye-Sync

Syncthink, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202927 is the FDA 510(k) clearance record for EYE-SYNC, a class II device, cleared for Syncthink, Inc. on under FDA product code QEA (Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid). FDA's definition for product code QEA reads: "A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid...". FDA records list 2 510(k) clearances for Syncthink, Inc., from to . As of , FDA records show one recall naming K202927.

Clearance record

Decision date
Received
(368 days to decision)
Product code
QEA Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
Regulation
21 CFR 882.1455
Device class
Class II
Review panel
Neurology
Applicant
Syncthink, Inc. 2172 Staunton Ct., Palo Alto CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QEA

Trailing 12 months
1 clearance under product code QEA in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QEA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260