510(k) Report

FDA applicant

Mediplus, Ltd.

High Wycombe, Bucks, GB4 decisions2002–20140 recalls

FDA records 4 decisions for Mediplus, Ltd. (High Wycombe, Bucks, GB) from 2002 to 2014: 4 510(k) clearances. Most are in product codes KLA (Monitor, Esophageal Motility, Anorectal…) and KOB (Catheter, Suprapubic (And Accessories)). Its devices cite 5 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2014

2013: 12014: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mediplus, 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 “Mediplus”

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