Hermes Medical Solutions AB: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Hermes Medical Solutions AB” (first 2012, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 165 days. Since 2017 the median was 166 days, against 125 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 232 |
| 2013 | 1 | 76 |
| 2014 | 2 | 93 |
| 2015 | 0 | — |
| 2016 | 1 | 224 |
| 2017 | 4 | 168 |
| 2018 | 1 | 143 |
| 2019 | 1 | 164 |
| 2020 | 2 | 90 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 178 |
| 2025 | 2 | 128 |
| 2026 | 1 | 242 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hermes Medical Solutions AB took a median 166 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 13 | 13 |
| QIH | Automated Radiological Image Processing Software | 2 | 2 |
| IYX | Camera, Scintillation (Gamma) | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (17)
Most recent Hermes Medical Solutions AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253835 | Affinity | QIH | 2026-07-31 | 242 |
| K252477 | Hybrid Viewer (00859873006240) | KPS | 2025-09-09 | 33 |
| K243919 | Voxel Dosimetry (00859873006226) | QIH | 2025-07-30 | 222 |
| K241364 | Hybrid Viewer (00859873006189) | KPS | 2024-11-08 | 178 |
| K202882 | Affinity | KPS | 2020-12-23 | 86 |
| K193152 | Affinity | KPS | 2020-02-14 | 93 |
| K191216 | Voxel Dosimetry v1.0 | LLZ | 2019-10-17 | 164 |
| K181468 | Hybrid3D | KPS | 2018-10-25 | 143 |
| K171719 | Hybrid3D | KPS | 2017-11-21 | 165 |
| K171681 | Hermes Medical Imaging Suite v5.7 | KPS | 2017-11-21 | 168 |
7 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2024-10-31.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hermes Medical Solutions AB?
FDA lists 17 510(k) clearances under the applicant name “Hermes Medical Solutions AB” (first 2012, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hermes Medical Solutions AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hermes Medical Solutions AB is 165 days. Since 2017: 166 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hermes Medical Solutions AB?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 13); QIH (Automated Radiological Image Processing Software, 2); IYX (Camera, Scintillation (Gamma), 1).
Next steps
- See all 17 Hermes Medical Solutions AB clearances with predicates and recalls
- Run predicate analysis for product code KPS, Hermes Medical Solutions AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.