510(k) · Cleared
Recalled · Class II · 2020Lifeport, Kidney Perfusion Transporter (KTR)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organ Recovery Systems, Inc. · KDN System, Perfusion, Kidney
Cleared on Jul 31, 2003 after a 457-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it. It has been recalled once.
- Decided
- Jul 31, 2003
- Review
- 457 days
- Class
- Class II
- Product code
- KDN
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK021362 Lifeport, Kidney Perfusion Transporter (KTR)Organ Recovery Systems, Inc. · 2003
- Descendant · cites it directly · 6 of its ownK123326 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK133694 Sherpa Pak TransporterParagonix Technologies, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK133432 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK203262 Cannula for Organ PerfusionBridge TO Life, Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK180194 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport…Paragonix Technologies, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K123326Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2013 · cites it directly6descendants
- K133694Sherpa Pak TransporterParagonix Technologies, Inc. · 2014 · 2 generations on3descendants
- K133432Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2014 · 2 generations on3descendants
- K203262Cannula for Organ PerfusionBridge TO Life, Ltd. · 2021 · cites it directly1descendant
- K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021362 | Lifeport, Kidney Perfusion Transporter (KTR) | Organ Recovery Systems, Inc. | 2003 | — |
| +1 | K123326 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2013 | — |
| +2 | K133694 | Sherpa Pak Transporter | Paragonix Technologies, Inc. | 2014 | — |
| +2 | K133432 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2014 | — |
| +1 | K203262 | Cannula for Organ Perfusion | Bridge TO Life, Ltd. | 2021 | — |
| +3 | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2020 | Class II | Z-1437-2020 | Reprocessing Controls | Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123326 (Paragonix Technologies, Inc., 2013) has gone furthest, with 6 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.
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?
LifePortTM, Kidney Perfusion Transporter (KTR) is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021362 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021362: Lifeport, Kidney Perfusion Transporter (KTR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021362
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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