510(k) Report

FDA applicant

Mentor Medical Limited

Hyth, Kent, GB1 decision2003–20030 recalls

FDA records 1 decision for Mentor Medical Limited (Hyth, Kent, GB) in 2003: 1 510(k) clearance. All are in product code JOH (Tube Tracheostomy And Tube Cuff). Its devices cite 7 predicates, 0 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 Mentor Medical Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mentor Medical Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mentor Medical Limited’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 “Mentor”

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