510(k) Report

FDA applicant

S.L.P., Ltd.

Tel-Aviv, IL5 decisions2004–20200 recalls

FDA records 5 decisions for S.L.P., Ltd. (Tel-Aviv, IL) from 2004 to 2020: 5 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and DQA (Oximeter). Its devices cite 12 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2020

2008: 12011: 12020: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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