510(k) · Decided
DecidedSherpa Pak Cardiac 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 Nov 25, 2014 as substantially equivalent to K133432 (Paragonix Technologies, Inc., 2014) and 2 other predicates after a 29-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Nov 25, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- MSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K883782 (1989). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK883782 Belzer UW-CSSDu Pont Critical Care · 1989
- 3 generations backK991594 Celsior Cold Flush, Storage and Transport Solution for HeartsSangstat Medical Corp. · 1999 · Recalled
- 2 generations backK123326 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2013
- 1 generation backK133432 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2014
- This deviceK143074 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883782 | Belzer UW-CSS | Du Pont Critical Care | 1989 | — |
| −3 | K991594 | Celsior Cold Flush, Storage and Transport Solution for Hearts | Sangstat Medical Corp. | 1999 | 1 |
| −2 | K123326 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2013 | — |
| −1 | K133432 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2014 | — |
| 0 (this device) | K143074 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K133432 | Sherpa Pak Cardiac Transport SystemSummary page 6…FR 876.5880 Product Code: MSB Predicate Devices: Sherpa Pak Cardiac Transport System (Paragonix Technologies, Inc) - K133432 Celsior Cold Storage Solution (SangStat Medical Corp) – K991594… | 2014 |
| * | K991594 | Celsior Cold Flush, Storage and Transport Solution for HeartsSummary page 6…Technologies, Inc) - K133432 Celsior Cold Storage Solution (SangStat Medical Corp) – K991594 Custodiol HTK (Dr Franz Köhler Chemie GmbH) – K032794 Device Description: The Paragonix She… | 1999 |
| * | K032794 | CustodiolSummary page 6…Celsior Cold Storage Solution (SangStat Medical Corp) – K991594 Custodiol HTK (Dr Franz Köhler Chemie GmbH) – K032794 Device Description: The Paragonix Sherpa Pak Cardiac Transport System is a device intended… | 2004 |
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 25 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 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. 2014, 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?
The Sherpa Pak 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 Sherpa Pak 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143074: Sherpa Pak Cardiac 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/K143074
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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