FDA applicant

Digio2 International Co., Ltd.

Flagstaff, AZ3 decisions2009–20140 recalls

FDA records 3 decisions for Digio2 International Co., Ltd. (Flagstaff, AZ) from 2009 to 2014: 3 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and FLL (Continuous Measurement Thermometer). 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 Digio2 International Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Digio2 International Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Digio2 International Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?