510(k) Report

FDA applicant

Gel-E, Inc. (Formerly Remedium Technologies, Inc.)

College Park, MD1 decision2017–20170 recalls

FDA records 1 decision for Gel-E, Inc. (Formerly Remedium Technologies, Inc.) (College Park, MD) in 2017: 1 510(k) clearance. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 1 predicate, 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 Gel-E, Inc. (Formerly Remedium Technologies, Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Gel-E, Inc. (Formerly Remedium Technologies, Inc.) by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gel-E, Inc. (Formerly Remedium…’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?

  • KGNWound Dressing With Animal-Derived Material (S)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) · 2017

The one decision as Gel-E, Inc. (Formerly Remedium Technologies, Inc.) →