510(k) Report

FDA applicant

Caesarea Medical Electronics, Ltd.

Caesarea, IL9 decisions2003–200848 recalls

FDA records 9 decisions for Caesarea Medical Electronics, Ltd. (Caesarea, IL) from 2003 to 2008: 9 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and LZH (Pump, Infusion, Enteral). 48 recalls are linked to its devices, 39 Class I.

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 Caesarea Medical Electronics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 22008: 1
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

46in 2020

2015: 12019: 1, 1 Class I2020: 46, 38 Class I
2007high 46 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

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