510(k) Report

FDA applicant

Iris USA

Pleasant Prairie, WI1 decision2023–20230 recalls

FDA records 1 decision for Iris USA (Pleasant Prairie, WI) in 2023: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). 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 and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Iris USA by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FXXMask, Surgical1decision

What has FDA decided for it lately?

  • K230380Surgical Face Masks, Model: EFMDS-L50Pn BLUIris USA · 2023

The one decision as Iris USA →

Other applicant names beginning “Iris”

FDA records each applicant name separately; these may or may not be the same firm.

Iris International, Inc. 3Iris Diagnostics 2Iris 1Iris International Inc., A Division of Iris Iris I 1Iris Optical, Inc. 1Iris Remote Imaging Systems 1Iris Molecular Diagnostics 1Iris Surgical, LLC 1Iris Medical Ent., Inc. 1Iris Diagnostics, A Division of Iris International, Inc. 1