Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Theranica Bioelectronics , Ltd. · 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) |
|---|---|---|---|---|---|
| K232152 | NerivioInfinity | Theranica Bioelectronics , Ltd. | 2023-11-08 | 112 | 0 |
| K223169 | Nerivio | Theranica Bioelectronics , Ltd. | 2023-02-06 | 118 | 0 |
| K203181 | Nerivio, FGD000075-4.7 | Theranica Bioelectronics , Ltd. | 2021-01-22 | 88 | 0 |
| DEN180059 | Nerivio Migra | Theranica Bioelectronics , Ltd. | 2019-05-20 | 195 | 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