510(k) Report

FDA applicant

Diagnostic Devices, Inc.

Deer Field, IL5 decisions2006–20090 recalls

FDA records 5 decisions for Diagnostic Devices, Inc. (Deer Field, IL) from 2006 to 2009: 5 510(k) clearances. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and DXH (Transmitters And Receivers…). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Diagnostic Devices Pty, Ltd.”.

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 Diagnostic Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 22009: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Diagnostic Devices, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Diagnostic Devices, Inc.’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?

  • NBWSystem, Test, Blood Glucose, Over The Counter3decisions
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision
  • CAFNebulizer (Direct Patient Interface)1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 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.

  • K073118Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 20084cite it
  • K060467Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 20062cite it
  • K053593ProdigyDiagnostic Devices, Inc. · 20061cites it

What has FDA decided for it lately?

  • K090307Ddi Ultrasonic Nebulizer SystemDiagnostic Devices, Inc. · 2009
  • K073118Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008
  • K072385Heartevent, Model atDiagnostic Devices Pty, Ltd. · 2008
  • K060467Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006
  • K053593ProdigyDiagnostic Devices, Inc. · 2006

All 4 as Diagnostic Devices, Inc. →The one decision as Diagnostic Devices Pty, Ltd. →

Other applicant names beginning “Diagnostic”

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

Diagnostic Products Corp. 324Diagnostic Systems Laboratories, Inc. 94Diagnostic Chemicals, Ltd. (Usa) 77Diagnostic Reagents, Inc. 66Diagnostic Chemicals, Ltd. 66Diagnostic Hybrids, Inc. 37Diagnostic Technology, Inc. 28Diagnostic Solutions, Inc. 26Diagnostic Ultrasound Corp. 16Diagnostic Systems 14Diagnostic Reagent Tech. 10Diagnostic Specialties 8