FDA applicant

Quantalx Neuroscience, Ltd.

Kfar Sava, IL3 decisions2024–20250 recalls

FDA records 3 decisions for Quantalx Neuroscience, Ltd. (Kfar Sava, IL) from 2024 to 2025: 2 510(k) clearances and 1 De Novo grant. Most are in product codes GXY (Electrode, Cutaneous) and GWF (Stimulator, Electrical, Evoked Response). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Quantalx Neuroscience”.

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 Quantalx Neuroscience, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2024high 2 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Quantalx Neuroscience, Ltd. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Quantalx”

FDA records each applicant name separately; these may or may not be the same firm.

Quantalx Neroscience 1

Quantalx Neuroscience, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Quantalx”