510(k) · Decided
DecidedSherpaPak Lung Preservation System , SherpaPak Liver Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pragonix Technologies · KDN System, Perfusion, Kidney
Cleared on Jan 16, 2020 after a 101-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jan 16, 2020
- Review
- 101 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK192869 SherpaPak Lung Preservation System , SherpaPak Liver Transport SystemPragonix Technologies · 2020
- Descendant · cites it directly · 0 of its ownK260456 VI°Port™ Liver Preservation SystemTraferox Technologies, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243870 X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK223874 BAROguardParagonix Technologies · 2023
Most influential descendants
Showing 3 of 3 · See all- K260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc. · 2026 · cites it directly0descendants
- K243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc. · 2025 · cites it directly0descendants
- K223874BAROguardParagonix Technologies · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K192869 | SherpaPak Lung Preservation System , SherpaPak Liver Transport System | Pragonix Technologies | 2020 | — |
| +1 | K260456 | VI°Port™ Liver Preservation System | Traferox Technologies, Inc. | 2026 | — |
| +1 | K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. | 2025 | — |
| +1 | K223874 | BAROguard | Paragonix Technologies | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K260456 (Traferox Technologies, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KDN devicesKDN System, Perfusion, Kidney: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 | — |
https://510kreport.com/device/K192869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K192869: SherpaPak Lung Preservation System , SherpaPak Liver Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K192869
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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