FDA applicant

Heartbeam, Inc.

Santa Clara, CA2 decisions2024–20250 recalls

FDA records 2 decisions for Heartbeam, Inc. (Santa Clara, CA) from 2024 to 2025: 2 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and MWJ (Electrocardiograph, Ambulatory (Without…). Its devices cite 2 predicates, 0 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 Heartbeam, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Heartbeam, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Heartbeam, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?