510(k) Report

FDA applicant

Epitel, Inc.

Salt Lake City, UT5 decisions2021–20250 recalls

FDA records 5 decisions for Epitel, Inc. (Salt Lake City, UT) from 2021 to 2025: 5 510(k) clearances. Most are in product codes OMC (Reduced- Montage Standard Electroencephalograph) and OMB (Automatic Event Detection Software For…). Since 2016 its 510(k)s took a median of 201 days from receipt to decision, against 201 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Epitel”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Epitel, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2021: 12023: 12024: 22025: 1
2021high 2 (2024) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Epitel, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Epitel, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OMCReduced- Montage Standard Electroencephalograph3decisions
  • OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 201 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 201 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203827REMIEpitel, Inc. · 20212cite it
  • K231779REMI AI Discrete Detection ModuleEpitel, Inc. · 20241cites it
  • K230933REMI Remote EEG Monitoring SystemEpitel, Inc. · 20231cites it

What has FDA decided for it lately?

  • K243185REMI Remote EEG Monitoring SystemEpitel · 2025
  • K240408REMI-AI Rapid Detection Module (REMI-AI RDM)Epitel, Inc. · 2024
  • K231779REMI AI Discrete Detection ModuleEpitel, Inc. · 2024
  • K230933REMI Remote EEG Monitoring SystemEpitel, Inc. · 2023
  • K203827REMIEpitel, Inc. · 2021

All 4 as Epitel, Inc. →The one decision as Epitel →