510(k) Report

FDA applicant

Rexaderm, Inc.

Northbrook, IL1 decision2008–20080 recalls

FDA records 1 decision for Rexaderm, Inc. (Northbrook, IL) in 2008: 1 510(k) clearance. All are in product code OLR (Oral Wound Dressing). Its devices cite 2 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 Rexaderm, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Rexaderm, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rexaderm, 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?

  • OLROral Wound Dressing1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K082553Rexastom Oral EaseRexaderm, Inc. · 2008

The one decision as Rexaderm, Inc. →