510(k) · Cleared
ClearedCustodiol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr. Franz Kohler Chemie GmbH · MSB System And Accessories, Isolated Heart, Transport And Preservation
Cleared on Apr 5, 2004 as substantially equivalent to K991594 (Sangstat Medical Corp., 1999) after a 210-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Apr 5, 2004
- Review
- 210 days
- Class
- Class II
- Product code
- MSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883782 (1989). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK883782 Belzer UW-CSSDu Pont Critical Care · 1989
- 1 generation backK991594 Celsior Cold Flush, Storage and Transport Solution for HeartsSangstat Medical Corp. · 1999 · Recalled
- This deviceK032794 CustodiolDr. Franz Kohler Chemie GmbH · 2004
- Descendant · cites it directly · 0 of its ownK143074 Sherpa Pak Cardiac Transport SystemParagonix Technologies, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K883782 | Belzer UW-CSS | Du Pont Critical Care | 1989 | — |
| −1 | K991594 | Celsior Cold Flush, Storage and Transport Solution for Hearts | Sangstat Medical Corp. | 1999 | 1 |
| 0 (this device) | K032794 | Custodiol | Dr. Franz Kohler Chemie GmbH | 2004 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K991594 | Celsior Cold Flush, Storage and Transport Solution for HeartsSummary page 1…ICES For its indication for use, the Custodiol HTK Solution is substantially equivalent to the Celsior Cold Storage Solution, which was cleared by FDA as K991594 for the single indication of heart preservation. For its specific formulation and other physical and chemical characteristic… | 1999 |
| * | — | Custodiol product Named without a submission number |
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 |
|---|---|---|---|
| K143074 | Sherpa Pak Cardiac Transport System | 2014 | 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 15 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K143074 (Paragonix Technologies, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K991594.
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?
Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys, livers, and hearts prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032794: Custodiol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032794
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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