FDA applicant

Somanetics Corp.

Troy, MI12 decisions1990–20100 recalls

FDA records 12 decisions for Somanetics Corp. (Troy, MI) from 1990 to 2010: 12 510(k) clearances. Most are in product codes DQA (Oximeter) and MUD (Oximeter, Tissue Saturation). Its devices cite 10 predicates, 6 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, cardiovascular panel, where it files most

How often FDA has decided Somanetics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Somanetics Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Somanetics Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?