510(k) Report

FDA applicant

Iris

Mchenry, IL1 decision1983–19830 recalls

FDA records 1 decision for Iris (Mchenry, IL) in 1983: 1 510(k) clearance. All are in product code JRE (Refractometer For Clinical Use). 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Iris since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Iris 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?

  • JRERefractometer For Clinical Use1decision

What has FDA decided for it lately?

  • K831213Specific Gravity InstrumentIris · 1983

The one decision as Iris →

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 International Inc., A Division of Iris Iris I 1Iris USA 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