510(k) Report

FDA applicant

Curamedical, BV

Claremont, NH2 decisions2005–20061 recall

FDA records 2 decisions for Curamedical, BV (Claremont, NH) from 2005 to 2006: 2 510(k) clearances. All are in product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil…). Its devices cite 2 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Curamedical, BV’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Curamedical, BV since 2007.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K051911Gelita-SponCuramedical, BV · 20051cites it
  • K060878Gelita-Spon Absorbable Gelatin Sponge, UspCuramedical, BV · 20061cites it

What has FDA decided for it lately?

  • K060878Gelita-Spon Absorbable Gelatin Sponge, UspCuramedical, BV · 20061 recall
  • K051911Gelita-SponCuramedical, BV · 2005

All 2 as Curamedical, BV →

What has been recalled?

1 recall linked to its devices; the latest:

  • K060878ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA…Jul 27, 2022Class II