510(k) Report

FDA applicant

Neuroelectrics Barcelona S.L.U.

Barcelona, ES2 decisions2017–20260 recalls

FDA records 2 decisions for Neuroelectrics Barcelona S.L.U. (Barcelona, ES) from 2017 to 2026: 2 510(k) clearances. All are in product code GWQ (Full-Montage Standard Electroencephalograph). Its devices cite 2 predicates, 1 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 Neuroelectrics Barcelona S.L.U.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 12026 (partial year): 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Neuroelectrics Barcelona S.L.U. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neuroelectrics Barcelona S.L.U.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GWQFull-Montage Standard Electroencephalograph2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 20171cites it

What has FDA decided for it lately?

  • K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U. · 2026
  • K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017

All 2 as Neuroelectrics Barcelona S.L.U. →