510(k) Report

FDA applicant

Del Mar Medical Systems, LLC

Irvine, CA2 decisions1999–20000 recalls

FDA records 2 decisions for Del Mar Medical Systems, LLC (Irvine, CA) from 1999 to 2000: 2 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and MWJ (Electrocardiograph, Ambulatory (Without…). 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 Del Mar Medical Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Del Mar Medical Systems, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Del Mar Medical Systems, LLC 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?

  • DQKComputer, Diagnostic, Programmable1decision
  • MWJElectrocardiograph, Ambulatory (Without Analysis)1decision

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.

  • K993620ImpresarioDel Mar Medical Systems, LLC · 19991cites it
  • K001317ARIADel Mar Medical Systems, LLC · 20001cites it

What has FDA decided for it lately?

  • K001317ARIADel Mar Medical Systems, LLC · 2000
  • K993620ImpresarioDel Mar Medical Systems, LLC · 1999

All 2 as Del Mar Medical Systems, LLC →