# K203262: Cannula for Organ Perfusion

- Pathway: 510(k) (Traditional)
- Applicant: Bridge TO Life, Ltd.
- Decided: Jul 1, 2021 after 238 days
- Product code: KDN (System, Perfusion, Kidney)
- 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 K902394 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021362: Lifeport, Kidney Perfusion Transporter (KTR), Organ Recovery Systems, Inc. (2003) Summary page 6.
- K902394: Resubmitted Multiorgan Perfusion Cannula, Fresenius USA, Inc. (1990) Summary page 6.

## Most influential descendants
- K222535: OCS Lung Donor Flush Set (2022), 0 descendants of its own

## Indications for use
Cannula for Organ Perfusion is a single-use device indicated for hypothermic flushing and replacement of residual blood in donor organs with a legally marketed organ preservation solution at the time of organ removal from the donor during the preparation of these organs for transplantation. This device is indicated for use with gravity flow; no testing has been provided for use with pump systems, such as mechanical perfusion devices.

Source page: https://510kreport.com/device/K203262
Methodology: https://510kreport.com/methodology