FDA applicant

Earlysense, Ltd.

Ramat-Gan, IL12 decisions2007–20180 recalls

FDA records 12 decisions for Earlysense, Ltd. (Ramat-Gan, IL) from 2007 to 2018: 12 510(k) clearances. Most are in product codes BZQ (Monitor, Breathing Frequency) and MSX (System, Network And Communication…). Its devices cite 22 predicates, 12 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, anesthesiology panel, where it files most

How often FDA has decided Earlysense, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2007high 2 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Earlysense, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?