Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioelectronics Corporation — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192234 | ActiPatch | Bioelectronics Corporation | 2020-01-31 | 165 | 0 |
| K190251 | RecoveryRx | Bioelectronics Corporation | 2019-06-28 | 141 | 0 |
| K152432 | ActiPatch(R) | Bioelectronics Corporation | 2017-02-03 | 526 | 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