FDA applicant
Hermes Medical Solutions AB
FDA records 17 decisions for Hermes Medical Solutions AB (Stockholm, SE) from 2012 to 2026: 17 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 167 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 19 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hermes Medical Solutions AB’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Hermes Medical Solutions AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report