510(k) Report

FDA applicant

Diagnosys, LLC

Lowell, MA1 decision2022–20220 recalls

FDA records 1 decision for Diagnosys, LLC (Lowell, MA) in 2022: 1 510(k) clearance. All are in product code GWE (Stimulator, Photic, Evoked Response). Its devices cite 1 predicate, 0 of them its own earlier devices. No 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 Diagnosys, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Diagnosys, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GWEStimulator, Photic, Evoked Response1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K221471E3 and ProfileDiagnosys, LLC · 2022

The one decision as Diagnosys, LLC →