510(k) Report

FDA applicant

Applied Cardiac Systems

Laguna Hills, CA5 decisions1982–20110 recalls

FDA records 5 decisions for Applied Cardiac Systems (Laguna Hills, CA) from 1982 to 2011: 5 510(k) clearances. Most are in product codes DSH (Recorder, Magnetic Tape, Medical) and DPS (Electrocardiograph). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Applied Cardiac Systems, Inc.”.

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 Applied Cardiac Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Applied Cardiac Systems’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?

  • DSHRecorder, Magnetic Tape, Medical2decisions
  • DPSElectrocardiograph1decision
  • DRNDevice, Counter-Pulsating, External1decision
  • QYXOutpatient Cardiac Telemetry1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K042413Acs Model NCP-2Applied Cardiac Systems · 20042cite it
  • K860249The Holter Reporter (TM)Applied Cardiac Systems · 19861cites it
  • K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc. · 20111cites it

What has FDA decided for it lately?

  • K103706The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc. · 2011
  • K042413Acs Model NCP-2Applied Cardiac Systems · 2004
  • K860249The Holter Reporter (TM)Applied Cardiac Systems · 1986
  • K833823Holter Performer Feather Weight/CassApplied Cardiac Systems · 1983
  • K813602Holter PerformerApplied Cardiac Systems · 1982

All 4 as Applied Cardiac Systems →The one decision as Applied Cardiac Systems, Inc. →