# K211314: OCS Lung Solution

- Pathway: 510(k) (Traditional)
- Applicant: TransMedics, Inc.
- Decided: Jul 29, 2021 after 90 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: 1 generation back to K000881 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000881: Perfadex Solution for Organ Preservation, Vitrolife Sweden AB (2001) Summary page 4.

## Indications for use
OCS™ Lung Solution is intended for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K211314
Methodology: https://510kreport.com/methodology