510(k) Report

FDA applicant

Sensible Medical Innovations, Ltd.

Netanya, IL2 decisions2015–20190 recalls

FDA records 2 decisions for Sensible Medical Innovations, Ltd. (Netanya, IL) from 2015 to 2019: 2 510(k) clearances. All are in product code DSB (Plethysmograph, Impedance). Its devices cite 7 predicates, 1 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 Sensible Medical Innovations, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2015: 12019: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Sensible Medical Innovations, Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Sensible”

FDA records each applicant name separately; these may or may not be the same firm.