Epitel, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Epitel, Inc.” (first 2021, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 172 days. Since 2017 the median was 172 days, against 146 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 90 |
| 2022 | 0 | — |
| 2023 | 1 | 88 |
| 2024 | 2 | 226 |
| 2025 | 1 | 172 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Epitel, Inc. took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | 3 | 3 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 2 | 2 |
Review panels
- Neurology (5)
Most recent Epitel, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243185 | REMI Remote EEG Monitoring System | OMC | 2025-03-21 | 172 |
| K240408 | REMI-AI Rapid Detection Module (REMI-AI RDM) | OMB | 2024-10-17 | 251 |
| K231779 | REMI AI Discrete Detection Module | OMB | 2024-01-03 | 201 |
| K230933 | REMI Remote EEG Monitoring System | OMC | 2023-06-30 | 88 |
| K203827 | REMI | OMC | 2021-03-29 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Epitel, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Epitel, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06027749: Impact of Capturing Ictal Events With Ultra-long-term Ambulatory EEG Monitoring With Remote EEG Monitoring System. (Recruiting, started 2023-10-13)
Frequently asked questions
How many FDA 510(k) clearances are listed under Epitel, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Epitel, Inc.” (first 2021, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Epitel, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Epitel, Inc. is 172 days. Since 2017: 172 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Epitel, Inc.?
The most frequent FDA product codes under this applicant name are OMC (Reduced- Montage Standard Electroencephalograph, 3); OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph, 2).
Next steps
- See all 5 Epitel, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OMC, Epitel, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.