X°Port Lung Preservation System; X°Port Lung Preservation Solution
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243870 FDA 510(k)
- FDA Product Code
- KDN FDA 510(k)
- Models / Variants
- X°Port Lung Preservation System FDA 510(k)X°Port Lung Preservation Solution FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5880 FDA 510(k)
- Regulation Number
- 876.5880 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The X°Port Lung Preservation System is a device intended for the static hypothermic preservation of lungs at 10°C with cold storage solutions indicated for use with lungs during transportation and preservation until transplantation into a recipient. It is designed to enable lung preservation and transport, overcoming geographical hurdles by allowing organs to be transported over longer distances without compromising quality.
The system is supplied as a perfusion system for kidney, classified as a Class II device under regulation number 876.5880, with product code KDN. It received FDA 510(k) clearance (K243870) on May 1, 2025, as substantially equivalent, and is manufactured by Traferox Technologies, Inc. in Mississauga, Ontario, Canada.
Frequently asked questions
What is the X°Port Lung Preservation System intended for?
The X°Port Lung Preservation System is intended for the static hypothermic preservation of lungs at 10°C using cold storage solutions, allowing lungs to be preserved and transported during transplantation procedures until they are implanted into a recipient.
How is the X°Port Lung Preservation System supplied and what is its classification?
The system is supplied as a perfusion system for kidney and is classified as a Class II medical device under regulation number 876.5880 with product code KDN, based on its FDA 510(k) clearance as substantially equivalent to a predicate device.
Does the X°Port Lung Preservation System include a preservation solution, and what temperature does it maintain?
Yes, the system includes the X°Port Lung Preservation Solution and is designed to maintain lungs at a static hypothermic temperature of 10°C during storage and transport, which helps preserve organ quality over longer distances.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lung Preservation and Transport - Traferox Technologies Inc., PDF X°Port Lung Preservation System - traferox.com, X°Port Lung Preservation System; X°Port Lung Preservation Solution ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243870 | Class II | Active |
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Manufacturer
- Manufacturer
- Traferox Technologies, Inc.
Sources (1)
- FDA 510(k) K243870 24 fields · synced Sep 24, 2026