510(k) Report

FDA applicant

Iris Diagnostics, A Division of Iris International, Inc.

Chatsworth, CA1 decision2017–20170 recalls

FDA records 1 decision for Iris Diagnostics, A Division of Iris International, Inc. (Chatsworth, CA) in 2017: 1 510(k) clearance. All are in product code JIL (Method, Enzymatic, Glucose (Urinary…). Its devices cite 1 predicate, 0 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, clinical chemistry panel, where it files most

How often FDA has decided Iris Diagnostics, A Division of Iris International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Iris Diagnostics, A Division of Iris International, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Iris Diagnostics, A Division of Iris…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 20171cites it

What has FDA decided for it lately?

  • K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017

The one decision as Iris Diagnostics, A Division of Iris International, Inc. →

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 USA 1Iris Optical, Inc. 1Iris Remote Imaging Systems 1Iris Molecular Diagnostics 1Iris Surgical, LLC 1Iris Medical Ent., Inc. 1