FDA applicant
Somnomedics GmbH
FDA records 8 decisions for Somnomedics GmbH (Randersacker, DE) from 2007 to 2024: 8 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and OLV (Standard Polysomnograph With…). Its devices cite 12 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Somnomedics GmbH & Co. KG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Somnomedics GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Somnomedics GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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