510(k) Report

FDA applicant

Acudata Software

Petaluma, CA7 decisions1988–19900 recalls

FDA records 7 decisions for Acudata Software (Petaluma, CA) from 1988 to 1990: 7 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and GXY (Electrode, Cutaneous). 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 Acudata Software’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Acudata Software since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Acudata Software by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Acudata Software’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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