510(k) Report

FDA applicant

Boule Medical AB

Plantation, FL2 decisions2004–20091 recall

FDA records 2 decisions for Boule Medical AB (Plantation, FL) from 2004 to 2009: 2 510(k) clearances. All are in product code GKZ (Counter, Differential Cell). 1 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, hematology panel, where it files most

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

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Boule Medical 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?

  • GKZCounter, Differential Cell2decisions

What has FDA decided for it lately?

  • K083420Medonic M SeriesBoule Medical AB · 20091 recall
  • K032214Medonic CA620/530 Hematology AnalyzerBoule Medical AB · 2004

All 2 as Boule Medical AB →

What has been recalled?

1 recall linked to its devices; the latest:

  • K083420Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product…Jan 2, 2020Class II