510(k) · Cleared
ClearedSherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragonix Technologies, Inc. · MSB System And Accessories, Isolated Heart, Transport And Preservation
Cleared on Mar 30, 2018 as substantially equivalent to K133432 (Paragonix Technologies, Inc., 2014) and 1 other predicate after a 65-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Mar 30, 2018
- Review
- 65 days
- Class
- Class II
- Product code
- MSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K944866 (1996). 11 ancestors in all, the oldest K883782 (1989). 1 later device descends from it, 1 citing it directly.
- 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 deviceK180194 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport…Paragonix Technologies, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK261913 X°Port Heart Preservation SystemTraferox Technologies, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261913X°Port Heart Preservation SystemTraferox Technologies, Inc. · 2026 · cites it directly0descendants
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) | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 K261913 X°Port Heart Preservation Systemscore 13.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K133432 | Sherpa Pak Cardiac Transport SystemSummary page 4…Class II Regulation Number: 21 CFR 876.5880 Product Code: MSB and KDN Predicate Devices: Sherpa Pak Cardiac Transport System (K133432) And Sherpa Pak Kidney Transport System (K133694) Device Description: The SherpaPak Cardiac Trans… | 2014 |
| * | K133694 | Sherpa Pak TransporterSummary page 4…MSB and KDN Predicate Devices: Sherpa Pak Cardiac Transport System (K133432) And Sherpa Pak Kidney Transport System (K133694) Device Description: The SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System result from modifications made… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261913 | X°Port Heart Preservation System | 2026 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K261913 (Traferox Technologies, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K133432.
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. 2018, 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?
SherpaPak Cardiac Transport System The SherpaPak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the SherpaPak Cardiac Transport System is up to 4 hours. Donor hearts exceeding clinically accepted static hypothermic preservation times should…
Read the full statement (151 words)
SherpaPak Cardiac Transport System
The SherpaPak Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart.
The intended organ storage time for the SherpaPak Cardiac Transport System is up to 4 hours.
Donor hearts exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.
SherpaPak Kidney Transport System
The SherpaPak 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 SherpaPak Kidney Transport System can maintain the donor organ storage temperature between 4̊ C and 8̊ C through 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180194: SherpaPak Cardiac Transport System and SherpaPak 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/K180194
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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