510(k) · Cleared
ClearedX°Port Heart Preservation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Traferox Technologies, Inc. · MSB System And Accessories, Isolated Heart, Transport And Preservation
Cleared on Sep 16, 2026 as substantially equivalent to K180194 (Paragonix Technologies, Inc., 2018) after a 100-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Sep 16, 2026
- Review
- 100 days
- Class
- Class II
- Product code
- MSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944866 (1996). 12 ancestors in all, the oldest K883782 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- 5 generations backK073693 CostorsolPreservation Solutions, Inc. · 2008 · Recalled
- 4 generations backK083453 CostorsolPreservation Solutions, Inc. · 2009
- 3 generations backK091245 CostorsolPreservation Solutions, Inc. · 2009
- 2 generations backK133694 Sherpa Pak TransporterParagonix Technologies, Inc. · 2014
- 1 generation backK180194 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport…Paragonix Technologies, Inc. · 2018
- This deviceK261913 X°Port Heart Preservation SystemTraferox Technologies, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| −5 | K073693 | Costorsol | Preservation Solutions, Inc. | 2008 | 2 |
| −4 | K083453 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| −3 | K091245 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| −2 | K133694 | Sherpa Pak Transporter | Paragonix Technologies, Inc. | 2014 | — |
| −1 | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018 | — |
| 0 (this device) | K261913 | X°Port Heart Preservation System | Traferox Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 MSB? 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 MSB device
- #1 K222535 OCS Lung Donor Flush Setscore 4.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemSummary page 5…edicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K180194 SherpaPak Cardiac Transport System MSB Device Description Summary… | 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 30 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 12 ancestors have a recall of any class.
How does its category compare?
All MSB devicesMSB System And Accessories, Isolated Heart, Transport And Preservation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MSB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MSB
Too few MSB 510(k)s in any year since 2007 to give a median.
Recalls per year · MSB
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSB
2in 2018
MAUDE reports naming product code MSB, 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 | 6 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The X°Port Heart Preservation System is indicated for static hypothermic preservation of donor hearts at 4–10 °C for up to 4 hours using a del Nido (or equivalent) cold storage solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261913: X°Port Heart Preservation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261913
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026