510(k) Report

FDA applicant

Harbinger Medical, Inc.

Eden Prairie, MN2 decisions2002–20090 recalls

FDA records 2 decisions for Harbinger Medical, Inc. (Eden Prairie, MN) from 2002 to 2009: 2 510(k) clearances. All are in product code DPS (Electrocardiograph). Its devices cite 7 predicates, 1 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 Harbinger Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Harbinger Medical, Inc.’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?

  • DPSElectrocardiograph2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 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.

  • K013615Micro-Induction 1000 SystemHarbinger Medical, Inc. · 20021cites it

What has FDA decided for it lately?

  • K090249Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2009
  • K013615Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2002

All 2 as Harbinger Medical, Inc. →