FDA applicant

Huntleigh Diagnostics, Ltd.

Cardiff Wales, GB3 decisions2000–20020 recalls

FDA records 3 decisions for Huntleigh Diagnostics, Ltd. (Cardiff Wales, GB) from 2000 to 2002: 3 510(k) clearances. Most are in product codes HGM (System, Monitoring, Perinatal) and LQK (Home Uterine Activity Monitor). Its devices cite 1 predicate, 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Huntleigh Diagnostics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Huntleigh Diagnostics, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Huntleigh Diagnostics, 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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Other applicant names beginning “Huntleigh”

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

Huntleigh Healthcare, Inc. 27 Huntleigh Technology, Inc. 23 Huntleigh Group, Ltd. 1

Huntleigh Diagnostics, Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Huntleigh”