510(k) Report

FDA applicant

Toul Meditech AB

Vasteras, SE3 decisions2016–20190 recalls

FDA records 3 decisions for Toul Meditech AB (Vasteras, SE) from 2016 to 2019: 3 510(k) clearances. All are in product code ORC (Air Filter Portable Apparatus). Its devices cite 3 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2019

2016: 12017: 12019: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Toul Meditech AB by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ORCAir Filter Portable Apparatus3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K153498OperioToul Meditech AB · 20162cite it

What has FDA decided for it lately?

  • K190027SteriStayToul Meditech AB · 2019
  • K173349OperioToul Meditech AB · 2017
  • K153498OperioToul Meditech AB · 2016

All 3 as Toul Meditech AB →