Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nordicneurolab AS — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
269 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251937 | nordicAudio (1.0) | Nordicneurolab AS | 2026-03-20 | 269 | 0 |
| K243209 | nordicMEDiVA | Nordicneurolab AS | 2024-10-22 | 21 | 0 |
| K241608 | nordicMEDiVA | Nordicneurolab AS | 2024-06-28 | 24 | 0 |
| K232680 | fMRI Hardware System | Nordicneurolab AS | 2023-12-13 | 103 | 0 |
| K212720 | nordicDSC | Nordicneurolab AS | 2022-03-03 | 188 | 0 |
| K191032 | fMRI Hardware System | Nordicneurolab AS | 2019-11-27 | 223 | 0 |
| K163324 | nordicBrainEx | Nordicneurolab AS | 2017-01-27 | 63 | 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