FDA applicant

Bardy Diagnostics, Inc.

Seattle, WA7 decisions2014–20230 recalls

FDA records 7 decisions for Bardy Diagnostics, Inc. (Seattle, WA) from 2014 to 2023: 7 510(k) clearances. All are in product code DSH (Recorder, Magnetic Tape, Medical). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 76 for FDA’s reviews in the same codes and years. 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 Bardy Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014high 3 (2019) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Bardy Diagnostics, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Bardy Diagnostics, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

What has FDA decided for it lately?