510(k) Report

FDA applicant

Iris International Inc., A Division of Iris Iris I

Chatsworth, CA1 decision2011–201111 recalls

FDA records 1 decision for Iris International Inc., A Division of Iris Iris I (Chatsworth, CA) in 2011: 1 510(k) clearance. All are in product code KQO (Automated Urinalysis System). Its devices cite 2 predicates, 0 of them its own earlier devices. 11 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, clinical chemistry panel, where it files most

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

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

2in 2020

2015: 12016: 12017: 22018: 32019: 22020: 2
2011high 3 (2018) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Iris International Inc., A Division of Iris Iris I by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KQOAutomated Urinalysis System1decision

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 2 times; 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.

  • K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 20112cite it

What has FDA decided for it lately?

  • K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 201111 recalls

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

What has been recalled?

11 recalls linked to its devices; the latest:

  • K101852iChem¿VELOCITY Urine Chemistry System-Mar 30, 2020Class II
  • K101852iChemVELOCITY Strips, Catalog 800-7212Feb 17, 2020Class II
  • K101852iChem VELOCITY Urine Chemistry AnalyzerNov 7, 2019Class II
  • K101852iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001…Oct 28, 2019Class II
  • K101852iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name…Oct 18, 2018Class II
  • K101852iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem…Mar 29, 2018Class 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 Diagnostics 2Iris 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