# P160013: Organ Care System (OCS™) Lung System

- Pathway: PMA
- Applicant: TransMedics, Inc.
- Decided: Mar 22, 2018 after 693 days
- Product code: QBA (Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation)
- Device class: 3
- Recalls of this device: none
- 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.

Source page: https://510kreport.com/device/P160013
Methodology: https://510kreport.com/methodology