510(k) Report

FDA applicant

Artsana S.P.A

Bristol, WI3 decisions2005–20160 recalls

FDA records 3 decisions for Artsana S.P.A (Bristol, WI) from 2005 to 2016: 3 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). 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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Artsana S.P.A’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Artsana S.P.A 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?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • FMFSyringe, Piston1decision

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 4 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.

  • K151311Safe Block Pen NeedleArtsana S.P.A · 20162cite it
  • K051783Artsana Pen Needles, Artsana Injection NeedlesArtsana S.P.A · 20052cite it

What has FDA decided for it lately?

  • K151311Safe Block Pen NeedleArtsana S.P.A · 2016
  • K052667Artsana Piston and Insulin SyringesArtsana S.P.A · 2005
  • K051783Artsana Pen Needles, Artsana Injection NeedlesArtsana S.P.A · 2005

All 3 as Artsana S.P.A →