510(k) Report

FDA applicant

Oceania Health Care Systems, Inc.

Palo Alto, CA1 decision1994–19940 recalls

FDA records 1 decision for Oceania Health Care Systems, Inc. (Palo Alto, CA) in 1994: 1 510(k) clearance. All are in product code LNX (Unnamed device). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Oceania Health Care Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oceania Health Care Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oceania Health Care Systems, Inc. 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?

  • LNXUnnamed device1decision

What has FDA decided for it lately?

  • K921846Oceania Health Care Systems Electronic Medical RecOceania Health Care Systems, Inc. · 1994

The one decision as Oceania Health Care Systems, Inc. →