510(k) · Cleared
ClearedSherpa Pak Transporter
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 May 23, 2014 as substantially equivalent to K123326 (Paragonix Technologies, Inc., 2013) and 1 other predicate after a 171-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.
- Decided
- May 23, 2014
- Review
- 171 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K944866 (1996). 9 ancestors in all, the oldest K883782 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- 3 generations backK073693 CostorsolPreservation Solutions, Inc. · 2008 · Recalled
- 2 generations backK083453 CostorsolPreservation Solutions, Inc. · 2009
- 1 generation backK091245 CostorsolPreservation Solutions, Inc. · 2009
- This deviceK133694 Sherpa Pak TransporterParagonix Technologies, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK180194 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport…Paragonix Technologies, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK261913 X°Port Heart Preservation SystemTraferox Technologies, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK143054 Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. · 2018 · cites it directly1descendant
- K261913X°Port Heart Preservation SystemTraferox Technologies, Inc. · 2026 · 2 generations on0descendants
- K143054Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| −3 | K073693 | Costorsol | Preservation Solutions, Inc. | 2008 | 2 |
| −2 | K083453 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| −1 | K091245 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| 0 (this device) | K133694 | Sherpa Pak Transporter | Paragonix Technologies, Inc. | 2014 | — |
| +1 | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018 | — |
| +2 | K261913 | X°Port Heart Preservation System | Traferox Technologies, Inc. | 2026 | — |
| +1 | 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 | 1 | 0 |
| 2003 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K123326 | Sherpa Pak Cardiac Transport SystemSummary page 1…de: KDN Predicate Devices: Sherpa Pak Cardiac Transport System, 21 CFR 876.5880 - Paragonix Technologies, Inc., K123326, Product Code MSB Avid Medical Custom Procedure Tray, 21 CFR 878.4800 -… | 2013 |
| * | K091245 | CostorsolSummary page 1…id Medical, Class I exempt, Product Code KDD CoStorSol, 21 CFR 876.5880. Preservation Solutions Inc. - K09 1245, Product Code KDN Device Description: The Paragonix Sherpa Pak Kidney Transport System is a… | 2009 |
| * | — | Avid Medical Custom Procedure Tray Named without a submission number |
What descends from it? (3)
2 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K180194 (Paragonix Technologies, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K123326.
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 this organ.
The Sherpa Pak Kidney Transport System can maintain the donor organ storage temperature between 4 0C and 80C through 24 hours.
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/K133694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133694: Sherpa Pak Transporter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133694
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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