Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Epitel, Inc. — 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) |
|---|---|---|---|---|---|
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | Epitel, Inc. | 2024-10-17 | 251 | 0 |
| K231779 | REMI AI Discrete Detection Module | Epitel, Inc. | 2024-01-03 | 201 | 0 |
| K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | 2023-06-30 | 88 | 0 |
| K203827 | REMI | Epitel, Inc. | 2021-03-29 | 90 | 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