510(k) Report

FDA applicant

Barnev, Ltd.

Kfar Saba, IL3 decisions2007–20090 recalls

FDA records 3 decisions for Barnev, Ltd. (Kfar Saba, IL) from 2007 to 2009: 2 510(k) clearances and 1 De Novo grant. All are in product code NPB (System, Monitoring, For Progress Of Labor). Its devices cite 4 predicates, 2 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, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2009

2007: 12008: 12009: 1
2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Barnev, 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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