FDA applicant

Biometrix, Ltd.

Jerusalem, IL4 decisions1993–20150 recalls

FDA records 4 decisions for Biometrix, Ltd. (Jerusalem, IL) from 1993 to 2015: 4 510(k) clearances. Most are in product codes DRS (Transducer, Blood-Pressure, Extravascular) and KPE (Container, I.V.). 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2015

2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biometrix, Ltd.’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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Biometrix, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?