510(k) · Decided
DecidedSherpa Pak Kidney Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragonix Technologies, Inc. · KDN System, Perfusion, Kidney
Cleared on Nov 25, 2014 as substantially equivalent to K133694 (Paragonix Technologies, Inc., 2014) and 4 other predicates after a 33-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Nov 25, 2014
- Review
- 33 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K944866 (1996). 14 ancestors in all, the oldest K883782 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- 4 generations backK073693 CostorsolPreservation Solutions, Inc. · 2008 · Recalled
- 3 generations backK083453 CostorsolPreservation Solutions, Inc. · 2009
- 2 generations backK091245 CostorsolPreservation Solutions, Inc. · 2009
- 1 generation backK133694 Sherpa Pak TransporterParagonix Technologies, Inc. · 2014
- This deviceK143054 Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| −4 | K073693 | Costorsol | Preservation Solutions, Inc. | 2008 | 2 |
| −3 | K083453 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| −2 | K091245 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| −1 | K133694 | Sherpa Pak Transporter | Paragonix Technologies, Inc. | 2014 | — |
| 0 (this device) | K143054 | Sherpa Pak Kidney Transport System | Paragonix Technologies, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1999 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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? (5)
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 |
|---|---|---|---|
| * | K133694 | Sherpa Pak TransporterSummary page 6…Subsequent - PIN Predicate Devices: Sherpa Pak Kidney Transport System (Paragonix Technologies, Inc) - K133694 Belzer UW Cold Storage Solution (DuPont Merk Pharmaceutical Company) -… | 2014 |
| * | K944866 | Viaspan (Belzer UW - CSS)Summary page 6…Technologies, Inc) - K133694 Belzer UW Cold Storage Solution (DuPont Merk Pharmaceutical Company) - K944866 CoStorSol (Preservation Solutions Inc) – K091245 SPS-1 (Organ Recovery… | 1996 |
| * | K091245 | CostorsolSummary page 6…W Cold Storage Solution (DuPont Merk Pharmaceutical Company) - K944866 CoStorSol (Preservation Solutions Inc) – K091245 SPS-1 (Organ Recovery Systems, Inc) – K091656 Custodiol HTK Solution (D… | 2009 |
| * | K091656 | SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2LSummary page 6…tical Company) - K944866 CoStorSol (Preservation Solutions Inc) – K091245 SPS-1 (Organ Recovery Systems, Inc) – K091656 Custodiol HTK Solution (Dr Franz Köhler Chemie GmbH) – K043461 Device… | 2010 |
| * | K043461 | CustodiolSummary page 6…SPS-1 (Organ Recovery Systems, Inc) – K091656 Custodiol HTK Solution (Dr Franz Köhler Chemie GmbH) – K043461 Device Description: The Paragonix Sherpa Pak Kidney Transport System is a device intended… | 2005 |
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 18 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 5 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K133694.
How does its category compare?
All KDN devicesKDN System, Perfusion, Kidney: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Sherpa Pak Kidney Transport System is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with these organs.
The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4°C and 8°C through 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143054: Sherpa Pak Kidney Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143054
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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