510(k) · Cleared
ClearedSherpa 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 Feb 21, 2014 as substantially equivalent to K123326 (Paragonix Technologies, Inc., 2013) and 1 other predicate after a 108-day review. Its family tree reaches back 3 generations to 1989. 3 later devices descend from it.
- Decided
- Feb 21, 2014
- Review
- 108 days
- Class
- Class II
- Product code
- MSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K883782 (1989). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK883782 Belzer UW-CSSDu Pont Critical Care · 1989
- 2 generations backK991594 Celsior Cold Flush, Storage and Transport Solution for HeartsSangstat Medical Corp. · 1999 · Recalled
- 1 generation backK123326 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2013
- This deviceK133432 Sherpa Pak Cardiac Transport SystemParagonix 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 ownK143074 Sherpa Pak Cardiac 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
- K143074Sherpa Pak Cardiac 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 |
|---|---|---|---|---|---|
| −3 | K883782 | Belzer UW-CSS | Du Pont Critical Care | 1989 | — |
| −2 | K991594 | Celsior Cold Flush, Storage and Transport Solution for Hearts | Sangstat Medical Corp. | 1999 | 1 |
| −1 | K123326 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2013 | — |
| 0 (this device) | K133432 | Sherpa Pak Cardiac Transport System | 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 | 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 |
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 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 |
|---|---|---|---|
| * | K123326 | Sherpa Pak Cardiac Transport SystemSummary page 1…Preservation Regulation Number: 21 CFR 876.5880 Product Code: MSB Predicate Devices: Sherpa Pak Cardiac Transport Systemn (K 123326) Celsior (K99 1594) Device Description: The Paragonix Sherpa Pak Cardiac Transport System… | 2013 |
| * | K991594 | Celsior Cold Flush, Storage and Transport Solution for HeartsSummary page 1…21 CFR 876.5880 Product Code: MSB Predicate Devices: Sherpa Pak Cardiac Transport Systemn (K 123326) Celsior (K99 1594) Device Description: The Paragonix Sherpa Pak Cardiac Transport System is a device intend… | 1999 |
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 25 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 2 of the 5 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 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 limes 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/K133432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133432: 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/K133432
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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