510(k) Report

FDA applicant

Bregas AB

Bromma, SE2 decisions2000–20030 recalls

FDA records 2 decisions for Bregas AB (Bromma, SE) from 2000 to 2003: 2 510(k) clearances. All are in product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). 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 Bregas AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bregas AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bregas 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?

  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase2decisions

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.

  • K023820CO2 ClipBregas AB · 20031cites it

What has FDA decided for it lately?

All 2 as Bregas AB →