510(k) Report

FDA applicant

Armadillo Biomedical, LLC

Irvine, CA2 decisions2012–20150 recalls

FDA records 2 decisions for Armadillo Biomedical, LLC (Irvine, CA) from 2012 to 2015: 2 510(k) clearances. All are in product code OKS (Lacrimal Stents And Intubation Sets). Its devices cite 2 predicates, 1 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 Armadillo Biomedical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2012: 12015: 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 — Armadillo Biomedical, LLC 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?

  • OKSLacrimal Stents And Intubation Sets2decisions

Whose devices does it build on?

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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K113508DacryocathArmadillo Biomedical, LLC · 20121cites it

What has FDA decided for it lately?

  • K142914DacryoCATHArmadillo Biomedical, LLC · 2015
  • K113508DacryocathArmadillo Biomedical, LLC · 2012

All 2 as Armadillo Biomedical, LLC →