510(k) Report

FDA applicant

Medical House Products Limited

Sheffield, GB2 decisions2006–20080 recalls

FDA records 2 decisions for Medical House Products Limited (Sheffield, GB) from 2006 to 2008: 2 510(k) clearances. Most are in product codes KZE (Injector, Fluid, Non-Electrically Powered) and KZH (Introducer, Syringe Needle). 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, general hospital panel, where it files most

How often FDA has decided Medical House Products Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KZEInjector, Fluid, Non-Electrically Powered1decision
  • KZHIntroducer, Syringe Needle1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K082587Auto-Safety Injector-2 (Asi-2)Medical House Products Limited · 2008
  • K060819Cool.Click 2Medical House Products Limited · 2006

All 2 as Medical House Products Limited →