# P200035: OrganOx metra System

- Pathway: PMA
- Applicant: Organox Limited
- Decided: Dec 9, 2021 after 512 days
- Product code: QQK (Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 15, 2024 · Class II · Z-0501-2025: Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

Source page: https://510kreport.com/device/P200035
Methodology: https://510kreport.com/methodology