Data / Medical devices / United Kingdom / Organox Limited
Organox Limited: FDA-registered device maker in Oxford Oxfordshire, United Kingdom, 1 510(k) clearance and 1 PMA approval
Organox Limited is registered with the FDA (registration 3011560054) in Oxford Oxfordshire, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated December 9, 2021. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3011560054
- Address
- 3500 John Smith Drive Oxford Business Park, Oxford Oxfordshire, United Kingdom, OX4 2WB
- Owner or operator
- OrganOx Limited (10084836)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 6, 2022
- Registered through
- 2027
- Brand names listed
- OrganOx metra, OrganOx metra Liver Perfusion Circuit Pack
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | DRY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation | QQK | 3 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2014 | K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | DRY | Substantially Equivalent | Terumo Cardiovascular Systems Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 9, 2021 | P200035 | OrganOx metra System | QQK | 40 | October 9, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 15, 2024 | 95581 | Class II | Ongoing | OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined f | Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- All makers of Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.