510(k) · Cleared
ClearedX°Port Lung Preservation System; X°Port Lung Preservation Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Traferox Technologies, Inc. · KDN System, Perfusion, Kidney
Cleared on May 1, 2025 as substantially equivalent to K192869 (Pragonix Technologies, 2020) and 1 other predicate after a 135-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- May 1, 2025
- Review
- 135 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000881 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK000881 Perfadex Solution for Organ PreservationVitrolife Sweden AB · 2001
- 4 generations backK022730 Perfadex Solution for Lung PreservationVitrolife AB · 2003
- 3 generations backK081997 Perfadex with ThamVitrolife Sweden AB · 2008 · Recalled
- 2 generations backK091989 Perfadex and Perfadex with ThamXvivo Perfusion AB · 2010
- 1 generation backK240650 LungProtectTraferox Technologies, Inc. · 2024
- This deviceK243870 X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000881 | Perfadex Solution for Organ Preservation | Vitrolife Sweden AB | 2001 | — |
| −4 | K022730 | Perfadex Solution for Lung Preservation | Vitrolife AB | 2003 | — |
| −3 | K081997 | Perfadex with Tham | Vitrolife Sweden AB | 2008 | 1 |
| −2 | K091989 | Perfadex and Perfadex with Tham | Xvivo Perfusion AB | 2010 | — |
| −1 | K240650 | LungProtect | Traferox Technologies, Inc. | 2024 | — |
| 0 (this device) | K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KDN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KDN device
- #1 K261644 Perfadex Plusscore 12.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192869 | SherpaPak Lung Preservation System , SherpaPak Liver Transport SystemSummary page 6…Page 2 of 6 Predicate Devices First Device Predicate Name: SherpaPak™ Lung Preservation System 510(k) Number: K192869 Regulation Name: Isolated kidney perfusion and transport system and accessories. Classification name: System,… | 2020 |
| * | K240650 | LungProtectSummary page 6…vation and transport device Regulation Number: 876.5880 Product Code: KDN Second Device Predicate Name: LungProtect 510(k) Number: K240650 Regulation Name: Isolated kidney perfusion and transport system and accessories. Classification name: System, Per… | 2024 |
| † | K170826 | Perfadex Plus | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K192869.
How does its category compare?
All KDN devicesKDN System, Perfusion, Kidney: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KDN
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDN
135in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KDN
3in 2025
MAUDE reports naming product code KDN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 2 | — | 0 | 9 |
| 2021 | 3 | 238 | 0 | 1 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 5 | 135 | 0 | 3 |
| 2026 | 3 | 66 | 1 | — |
What is it indicated for?
The X°Port Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient. The X°Port Lung Preservation System is intended to be used with the X°Port Lung Preservation Solution. The intended organ storage time for the X°Port Lung Preservation System is up to 8 hours. When clinically accepted static hypothermic preservation times are exceeded, the lungs…
Read the full statement (125 words)
The X°Port Lung Preservation System is intended to be used for the static hypothermic preservation
of lungs during transportation and eventual transplantation into a recipient. The X°Port Lung
Preservation System is intended to be used with the X°Port Lung Preservation Solution.
The intended organ storage time for the X°Port Lung Preservation System is up to 8 hours.
When clinically accepted static hypothermic preservation times are exceeded, the lungs should be
evaluated by the transplant surgeon to determine transplantability in accordance with accepted
clinical guidelines and in the best medical interest of the intended recipient.
The X°Port Lung Preservation Solution is indicated for the flushing, cold static storage and
transportation of isolated lungs after removal from the donor in preparation for eventual
transplantation into a recipient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243870 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243870: X°Port Lung Preservation System; X°Port Lung Preservation Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243870
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026