510(k) Report

FDA applicant

Iris Diagnostics

Chatsworth, CA2 decisions2007–20102 recalls

FDA records 2 decisions for Iris Diagnostics (Chatsworth, CA) from 2007 to 2010: 2 510(k) clearances. Most are in product codes GKL (Counter, Cell, Automated (Particle Counter)) and JJW (Urinalysis Controls (Assayed And Unassayed)). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

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

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

FDA decisions per year

1in 2010

2007: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2024

2022: 12024: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Iris Diagnostics 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?

  • GKLCounter, Cell, Automated (Particle Counter)1decision
  • JJWUrinalysis Controls (Assayed And Unassayed)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 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.

  • K091539IQ 200 Urine Analizer Body Fluids ModuleIris Diagnostics · 20101cites it

What has FDA decided for it lately?

  • K091539IQ 200 Urine Analizer Body Fluids ModuleIris Diagnostics · 2010
  • K072640Irispec,CA/CB/CCIris Diagnostics · 20072 recalls

All 2 as Iris Diagnostics →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K072640Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211…Jul 16, 2024Class III
  • K072640BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.Nov 18, 2022Class II

Other applicant names beginning “Iris”

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

Iris International, Inc. 3Iris 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. 1Iris Diagnostics, A Division of Iris International, Inc. 1