510(k) Report

FDA applicant

Al.Chi.Mi.A. S.R.L

Hasbrouck Heights, NJ5 decisions2003–20250 recalls

FDA records 5 decisions for Al.Chi.Mi.A. S.R.L (Hasbrouck Heights, NJ) from 2003 to 2025: 4 510(k) clearances and 1 De Novo grant. Most are in product codes LYX (Media, Corneal Storage) and QCW (Corneal Storage Media With Preservatives…). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Al.Chi.Mi.A”.

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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Al.Chi.Mi.A. S.R.L’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12016: 12022: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Al.Chi.Mi.A. S.R.L 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?

  • LYXMedia, Corneal Storage4decisions
  • QCWCorneal Storage Media With Preservatives Including Anti-Fungal1decision

Whose devices does it build on?

Its devices cite 3 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.

  • K032422Eusol-CAl.Chi.Mi.A · 20031cites it

What has FDA decided for it lately?

  • K251320XTRA4Al.Chi.Mi.A. S.R.L · 2025
  • DEN200063KerasaveAl.Chi.Mi.A. S.R.L · 2022
  • K162013Eusol-CAl.Chi.Mi.A. S.R.L · 2016
  • K063617Eusol-CAl.Chi.Mi.A · 2007
  • K032422Eusol-CAl.Chi.Mi.A · 2003

All 3 as Al.Chi.Mi.A. S.R.L →All 2 as Al.Chi.Mi.A →