Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Neurologica Corporation, A Subsidiary of Samsung Electronics · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211711 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2022-02-25 | 267 | 0 |
| K202526 | OmniTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2020-12-23 | 113 | 1 |
| K172539 | CereTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017-11-22 | 91 | 0 |
| K170238 | BodyTom Elite | Neurologica Corporation, A Subsidiary of Samsung Electronics | 2017-06-14 | 139 | 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