510(k) Report

FDA applicant

Scibase AB

Stockholm1 decision2017–20170 recalls

FDA records 1 decision for Scibase AB (Stockholm) in 2017: 1 original PMA approval. All are in product code ONV (Electrical Impedance Spectrometer). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2017

2017: 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 — Scibase AB by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Scibase AB’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

Which product codes does it file in?

  • ONVElectrical Impedance Spectrometer1decision

What has FDA decided for it lately?

The one decision as Scibase AB →