# K222535: OCS Lung Donor Flush Set

- Pathway: 510(k) (Traditional)
- Applicant: TransMedics, Inc.
- Decided: Nov 18, 2022 after 88 days
- Product code: MSB (System And Accessories, Isolated Heart, Transport And Preservation)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902394 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203262: Cannula for Organ Perfusion, Bridge TO Life, Ltd. (2021) Summary page 4.

## Indications for use
The OCS™ Lung Donor Flush Set is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation.

Source page: https://510kreport.com/device/K222535
Methodology: https://510kreport.com/methodology