510(k) Report

FDA applicant

Artiglass Srl

Due Carrare, IT2 decisions2013–20220 recalls

FDA records 2 decisions for Artiglass Srl (Due Carrare, IT) from 2013 to 2022: 2 510(k) clearances. Most are in product codes QEH (Piston Syringe With Neuraxial Connector –…) 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 Artiglass Srl’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2013: 12022: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Artiglass Srl by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral…1decision
  • FMFSyringe, Piston1decision

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.

  • K122416Artiglass L. O.R. Glass SyringeArtiglass Srl · 20131cites it

What has FDA decided for it lately?

  • K213800Artiglass NRFitTM Tip L.O.R. Glass SyringesArtiglass Srl · 2022
  • K122416Artiglass L. O.R. Glass SyringeArtiglass Srl · 2013

All 2 as Artiglass Srl →