FDA applicant

Inpeco S.P.A.

Segrate, Milan, IT1 decision2012–201233 recalls

FDA records 1 decision for Inpeco S.P.A. (Segrate, Milan, IT) in 2012: 1 510(k) clearance. All are in product code CEM (Electrode, Ion Specific, Potassium). Its devices cite 1 predicate, 0 of them its own earlier devices. 33 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Inpeco S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

4in 2025

2012high 19 (2020) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Inpeco S.P.A. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Inpeco S.P.A.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?