# K231362: OCS Heart Leukocyte Depleting Filter

- Pathway: 510(k) (Traditional)
- Applicant: TransMedics, Inc.
- Decided: Oct 31, 2023 after 173 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- 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 K902518 (1990). 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)
- K902518: LD-Six Arterial Blood Filter for Extra. Service, Pall Biomedical Products Co. (1990) Summary page 4.

## Indications for use
The OCS™ Heart Leukocyte Depleting Filter is indicated for the reduction of leukocytes from donor blood prior to its introduction into the OCS™ Heart System for the preservation of a donor heart from the same donor.

Source page: https://510kreport.com/device/K231362
Methodology: https://510kreport.com/methodology