Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hermes Medical Solutions AB · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
165 daysmedian FDA review time
232 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253835 | Affinity | Hermes Medical Solutions AB | 2026-07-31 | 242 | 0 |
| K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | 2025-09-09 | 33 | 0 |
| K243919 | Voxel Dosimetry (00859873006226) | Hermes Medical Solutions AB | 2025-07-30 | 222 | 0 |
| K241364 | Hybrid Viewer (00859873006189) | Hermes Medical Solutions AB | 2024-11-08 | 178 | 0 |
| K202882 | Affinity | Hermes Medical Solutions AB | 2020-12-23 | 86 | 0 |
| K193152 | Affinity | Hermes Medical Solutions AB | 2020-02-14 | 93 | 0 |
| K191216 | Voxel Dosimetry™ v1.0 | Hermes Medical Solutions AB | 2019-10-17 | 164 | 0 |
| K181468 | Hybrid3D | Hermes Medical Solutions AB | 2018-10-25 | 143 | 0 |
| K171681 | Hermes Medical Imaging Suite v5.7 | Hermes Medical Solutions AB | 2017-11-21 | 168 | 1 |
| K171719 | Hybrid3D | Hermes Medical Solutions AB | 2017-11-21 | 165 | 0 |
| K163687 | OLINDA EXM | Hermes Medical Solutions AB | 2017-07-19 | 203 | 0 |
| K163394 | Hybrid3D | Hermes Medical Solutions AB | 2017-05-22 | 168 | 0 |
| K153056 | Hermes Medical Imaging Suite v5.6 | Hermes Medical Solutions AB | 2016-06-01 | 224 | 0 |
| K142631 | Hermes Medical Imaging Suite v5.5 | Hermes Medical Solutions AB | 2014-12-18 | 92 | 0 |
| K140269 | HERMES MEDICAL IMAGING SUITE V5.4 | Hermes Medical Solutions AB | 2014-05-08 | 94 | 0 |
| K131233 | HERMES MEDICAL IMAGING SUITE V5.3 | Hermes Medical Solutions AB | 2013-07-16 | 76 | 0 |
| K121278 | HERMES MEDICAL IMAGING SUITE V5.2 | Hermes Medical Solutions AB | 2012-12-18 | 232 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda