510(k) Report

FDA applicant

Innocoll Pharmaceuticals

Athlone, Co. Westmeath, IE8 decisions2006–20140 recalls

FDA records 8 decisions for Innocoll Pharmaceuticals (Athlone, Co. Westmeath, IE) from 2006 to 2014: 8 510(k) clearances. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 12 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Innocoll Pharmaceuticals, Ltd.”.

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

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

FDA decisions per year

1in 2014

2008: 12010: 22011: 22012: 12014: 1
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Innocoll Pharmaceuticals 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?

  • KGNWound Dressing With Animal-Derived Material (S)8decisions

Whose devices does it build on?

Its devices cite 12 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 8 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.

  • K092805Collagen SpongeInnocoll Pharmaceuticals · 20104cite it
  • K061746Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals · 20062cite it
  • K110388Collacare DentalInnocoll Pharmaceuticals, Ltd. · 20112cite it
  • K081782CollievaInnocoll Pharmaceuticals · 20081cites it
  • K133290Collacare DentalInnocoll Pharmaceuticals · 20141cites it

What has FDA decided for it lately?

  • K133290Collacare DentalInnocoll Pharmaceuticals · 2014
  • K120339ProcollInnocoll Pharmaceuticals · 2012
  • K103648Collagen PowderInnocoll Pharmaceuticals, Ltd. · 2011
  • K110388Collacare DentalInnocoll Pharmaceuticals, Ltd. · 2011
  • K100574CollexaInnocoll Pharmaceuticals · 2010
  • K092805Collagen SpongeInnocoll Pharmaceuticals · 2010
  • K081782CollievaInnocoll Pharmaceuticals · 2008
  • K061746Collaguard, Model Fcia,Fcib,Fcic,and FcidInnocoll Pharmaceuticals · 2006

All 6 as Innocoll Pharmaceuticals →All 2 as Innocoll Pharmaceuticals, Ltd. →