510(k) Report

FDA applicant

Munktell Filter AB

Mccordsville, IN2 decisions2002–20020 recalls

FDA records 2 decisions for Munktell Filter AB (Mccordsville, IN) in 2002: 2 510(k) clearances. All are in product code CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 7 predicates, 0 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Munktell Filter AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • CAHFilter, Bacterial, Breathing-Circuit2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K014282Bacstop Filter,Bacstop Filter/HmeMunktell Filter AB · 20021cites it

What has FDA decided for it lately?

  • K014282Bacstop Filter,Bacstop Filter/HmeMunktell Filter AB · 2002
  • K014281Gard Filter, Combigard Filte / HmeMunktell Filter AB · 2002

All 2 as Munktell Filter AB →