FDA applicant

Cardiac Insight, Inc.

Kirkland, WA3 decisions2013–20170 recalls

FDA records 3 decisions for Cardiac Insight, Inc. (Kirkland, WA) from 2013 to 2017: 3 510(k) clearances. All are in product code DSH (Recorder, Magnetic Tape, Medical). Its devices cite 4 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 Cardiac Insight, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Cardiac Insight, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiac Insight, 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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Cardiac Insight, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?