510(k) Report

FDA applicant

The Westaim Corp.

Exeter, NH1 decision2001–20010 recalls

FDA records 1 decision for The Westaim Corp. (Exeter, NH) in 2001: 1 510(k) clearance. All are in product code FRO (Dressing, Wound, Drug). 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 The Westaim Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for The Westaim Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — The Westaim Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • FRODressing, Wound, Drug1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K002896Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 20015cite it

What has FDA decided for it lately?

  • K002896Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001

The one decision as The Westaim Corp. →

Other applicant names beginning “The”

FDA records each applicant name separately; these may or may not be the same firm.

Westaim Biomedical, Inc. 6Westaim Technologies, Inc. 1