510(k) Report

FDA applicant

Medifactia AB

Gothenburg, SE2 decisions2019–20230 recalls

FDA records 2 decisions for Medifactia AB (Gothenburg, SE) from 2019 to 2023: 2 510(k) clearances. All are in product code FFX (System, Gastrointestinal Motility (Electrical)). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2023

2019: 12023: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Medifactia AB by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FFXSystem, Gastrointestinal Motility (Electrical)2decisions

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.

  • K181760Transit-PelletsMedifactia AB · 20191cites it

What has FDA decided for it lately?

  • K222000Transit-PelletsMedifactia AB · 2023
  • K181760Transit-PelletsMedifactia AB · 2019

All 2 as Medifactia AB →