510(k) Report

FDA applicant

Curaline, Inc.

Mequon, WI1 decision2012–20120 recalls

FDA records 1 decision for Curaline, Inc. (Mequon, WI) in 2012: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). Its devices cite 6 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 Curaline, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Curaline, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K121361Curaline Polyurethane Foam Awc DressingCuraline, Inc. · 2012

The one decision as Curaline, Inc. →