510(k) Report

FDA applicant

Macquarie Medical Systems

Chico, CA2 decisions1998–19980 recalls

FDA records 2 decisions for Macquarie Medical Systems (Chico, CA) in 1998: 2 510(k) clearances. All are in product code DPS (Electrocardiograph). Its devices cite 3 predicates, 0 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 Macquarie Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Macquarie Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Macquarie Medical Systems 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?

  • DPSElectrocardiograph2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K961798CT 200 ElectrocardiographMacquarie Medical Systems · 1998
  • K981951CT 100 ElectrocardiographMacquarie Medical Systems · 1998

All 2 as Macquarie Medical Systems →