510(k) Report

FDA applicant

Syncthink, Inc.

Palo Alto, CA2 decisions2016–20211 recall

FDA records 2 decisions for Syncthink, Inc. (Palo Alto, CA) from 2016 to 2021: 2 510(k) clearances. Most are in product codes QEA (Brain Injury Adjunctive Interpretive…) and GWN (Nystagmograph). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Syncthink, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2016: 12021: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2016high 1 (2023) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Syncthink, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid1decision
  • GWNNystagmograph1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202927Eye-SyncSyncthink, Inc. · 20211cites it
  • K152915Eye-SyncSyncthink, Inc. · 20161cites it

What has FDA decided for it lately?

  • K202927Eye-SyncSyncthink, Inc. · 20211 recall
  • K152915Eye-SyncSyncthink, Inc. · 2016

All 2 as Syncthink, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K202927NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2…Sep 19, 2023Class II