510(k) · Cleared
Recalled · Class II · 2025Celsior Cold Flush, Storage and Transport Solution for Hearts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sangstat Medical Corp. · MSB System And Accessories, Isolated Heart, Transport And Preservation
Cleared on Aug 5, 1999 as substantially equivalent to K900492 (The DU Pont Co., 1990) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1989. 9 later devices descend from it. It has been recalled once.
- Decided
- Aug 5, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- MSB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K883782 (1989). 2 ancestors in all. 9 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK883782 Belzer UW-CSSDu Pont Critical Care · 1989
- This deviceK991594 Celsior Cold Flush, Storage and Transport Solution for HeartsSangstat Medical Corp. · 1999
- Descendant · cites it directly · 6 of its ownK123326 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK133694 Sherpa Pak TransporterParagonix Technologies, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK133432 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK180194 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport…Paragonix Technologies, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK032794 CustodiolDr. Franz Kohler Chemie GmbH · 2004
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K123326Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2013 · cites it directly6descendants
- K133694Sherpa Pak TransporterParagonix Technologies, Inc. · 2014 · 2 generations on3descendants
- K133432Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2014 · cites it directly3descendants
- K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. · 2018 · 2 generations on1descendant
- K032794CustodiolDr. Franz Kohler Chemie GmbH · 2004 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883782 | Belzer UW-CSS | Du Pont Critical Care | 1989 | — |
| 0 (this device) | K991594 | Celsior Cold Flush, Storage and Transport Solution for Hearts | Sangstat Medical Corp. | 1999 | — |
| +1 | K123326 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2013 | — |
| +2 | K133694 | Sherpa Pak Transporter | Paragonix Technologies, Inc. | 2014 | — |
| +1 | K133432 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | 2014 | — |
| +2 | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018 | — |
| +1 | K032794 | Custodiol | Dr. Franz Kohler Chemie GmbH | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K900492 | Labeling Change - Viaspan (TM) (Belzer UW)Summary page 2…afety and Effectiveness Information III. Predicate Device A. Name ViaSpa.n® (Belzer UW-CSS), Du Pont Pharmaceuticals (Wilmington, Delaware) [510(k) Notification Number K900492 and K883782], Class Code with Panel Number 78-KDL. B. Indications for Use The solution is intended for flushing and cold storag… | 1990 |
| * | K883782 | Belzer UW-CSSSummary page 2…fectiveness Information III. Predicate Device A. Name ViaSpa.n® (Belzer UW-CSS), Du Pont Pharmaceuticals (Wilmington, Delaware) [510(k) Notification Number K900492 and K883782], Class Code with Panel Number 78-KDL. B. Indications for Use The solution is intended for flushing and cold storage for orgéns… | 1989 |
What descends from it? (9)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2025 | Class II | Z-2220-2025 | Under Investigation by firm | The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K123326 (Paragonix Technologies, Inc., 2013) has gone furthest, with 6 descendants of its own.
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.
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?
Celsior is intended for flushing and cold storage of a
heart at the time of its removal from a donor in
preparation for storage, transportation, and eventual
transplantation into a recipient.
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/K991594 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991594: Celsior Cold Flush, Storage and Transport Solution for Hearts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991594
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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