FDA applicant

Sonarmed, Inc.

Carmel, IN3 decisions2010–20206 recalls

FDA records 3 decisions for Sonarmed, Inc. (Carmel, IN) from 2010 to 2020: 3 510(k) clearances. All are in product code OQU (Airway Monitoring System). Its devices cite 7 predicates, 2 of them its own earlier devices. 6 recalls are linked to its devices, 4 Class I.

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 Sonarmed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

4in 2024

2010high 4 (2024) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Sonarmed, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sonarmed, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?