FDA applicant

Medical Electronic Systems, Ltd.

Caesarea, IL7 decisions2001–20250 recalls

FDA records 7 decisions for Medical Electronic Systems, Ltd. (Caesarea, IL) from 2001 to 2025: 7 510(k) clearances. All are in product code POV (Semen Analysis Device). Its devices cite 6 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Medical Electronic Systems, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

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

FDA decisions per year

1in 2025

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Electronic Systems, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Medical Electronic Systems, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?