FDA applicant

Epien Medical, Inc.

St. Paul, MN2 decisions2013–20210 recalls

FDA records 2 decisions for Epien Medical, Inc. (St. Paul, MN) from 2013 to 2021: 2 510(k) clearances. All are in product code KJJ (Cleanser, Root Canal). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

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

FDA decisions per year

1in 2021

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Epien Medical, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Epien Medical, 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

Epien Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?