510(k) Report

FDA applicant

Eme (Electro Medical Equipment), Ltd.

Brighton, Sussex, GB1 decision2001–20010 recalls

FDA records 1 decision for Eme (Electro Medical Equipment), Ltd. (Brighton, Sussex, GB) in 2001: 1 510(k) clearance. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). 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 Eme (Electro Medical Equipment), Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eme (Electro Medical Equipment), Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eme (Electro Medical Equipment), Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Eme (Electro Medical Equipment), 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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Which product codes does it file in?

  • BZDVentilator, Non-Continuous (Respirator)1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011516Infant Flow System, Model M672PEme (Electro Medical Equipment), Ltd. · 20013cite it

What has FDA decided for it lately?

  • K011516Infant Flow System, Model M672PEme (Electro Medical Equipment), Ltd. · 2001

The one decision as Eme (Electro Medical Equipment), Ltd. →