FDA applicant

Exceleron Medical

St. Paul, MN2 decisions2014–20240 recalls

FDA records 2 decisions for Exceleron Medical (St. Paul, MN) from 2014 to 2024: 2 510(k) clearances. Most are in product codes BZE (Heater, Breathing System W/Wo Controller (Not…) and CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 3 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 Exceleron Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Exceleron Medical by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Exceleron Medical

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?