510(k) Report

FDA applicant

Diagnostic Monitoring Software

Stateline, NV5 decisions1992–20140 recalls

FDA records 5 decisions for Diagnostic Monitoring Software (Stateline, NV) from 1992 to 2014: 5 510(k) clearances. Most are in product codes MWJ (Electrocardiograph, Ambulatory (Without…) and DSH (Recorder, Magnetic Tape, Medical). Its devices cite 7 predicates, 3 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • MWJElectrocardiograph, Ambulatory (Without Analysis)2decisions
  • DSHRecorder, Magnetic Tape, Medical1decision
  • DQKComputer, Diagnostic, Programmable1decision
  • MLOElectrocardiograph, Ambulatory, With Analysis Algorithm1decision

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062007DMS 300-7Diagnostic Monitoring Software · 20061cites it
  • K911615Holter 24-Hour Ecg System, Model Number: DMS 300Diagnostic Monitoring Software · 19921cites it
  • K062959DMS 300-2, 300-3 and 300-4Diagnostic Monitoring Software · 20061cites it

What has FDA decided for it lately?

  • K133014DMS 300-2W Holter Ecg RecorderDiagnostic Monitoring Software · 2014
  • K062959DMS 300-2, 300-3 and 300-4Diagnostic Monitoring Software · 2006
  • K062088Premier 11 HolterDiagnostic Monitoring Software · 2006
  • K062007DMS 300-7Diagnostic Monitoring Software · 2006
  • K911615Holter 24-Hour Ecg System, Model Number: DMS 300Diagnostic Monitoring Software · 1992

All 5 as Diagnostic Monitoring Software →

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