510(k) Report

FDA applicant

Organox Limited

Oxford1 decision2021–20211 recall

FDA records 1 decision for Organox Limited (Oxford) in 2021: 1 original PMA approval. All are in product code QQK (Normothermic Machine Perfusion System For The…). 1 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 Organox Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2021high 1 (2024) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Organox Limited by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QQKNormothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To…1decision

What has FDA decided for it lately?

  • P200035OrganOx metra SystemOrganox Limited · 20211 recall

The one decision as Organox Limited →

What has been recalled?

1 recall linked to its devices; the latest:

  • P200035OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport…Oct 15, 2024Class II