510(k) · Cleared
Recalled · Class II · 2024Custodiol HTK Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr. Franz Kohler Chemie GmbH · KDL Set, Perfusion, Kidney, Disposable
Cleared on Apr 24, 2020 as substantially equivalent to K043461 (Dr. Franz Kohler Chemie GmbH, 2005) after a 233-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 24, 2020
- Review
- 233 days
- Class
- Class II
- Product code
- KDL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944866 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- 3 generations backK992209 CustodiolDr. Franz Kohler Chemie GmbH · 1999
- 2 generations backK020924 Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2003
- 1 generation backK043461 CustodiolDr. Franz Kohler Chemie GmbH · 2005
- This deviceK192408 Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2020
- Descendant · cites it directly · 0 of its ownK241239 OrganProtex HTK SolutionBridge TO Life, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241239OrganProtex HTK SolutionBridge TO Life, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| −3 | K992209 | Custodiol | Dr. Franz Kohler Chemie GmbH | 1999 | — |
| −2 | K020924 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2003 | — |
| −1 | K043461 | Custodiol | Dr. Franz Kohler Chemie GmbH | 2005 | — |
| 0 (this device) | K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2020 | — |
| +1 | K241239 | OrganProtex HTK Solution | Bridge TO Life, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 KDL? 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 KDL device
- #1 K241239 OrganProtex HTK Solutionscore 9.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K043461 | CustodiolSummary page 5…Holder CUSTODIOL® HTK CUSTODIOL® HTK Dr. Franz Köhler Chemie N.A. K043461 Solution Solution GmbH 3. Device Description The CUSTODIOL® HTK solution is i… | 2005 |
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 |
|---|---|---|---|
| K241239 | OrganProtex HTK Solution | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2024 | Class II | Z-3300-2024 | Device Design | Potential for particles to be present in solution. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K241239 (Bridge TO Life, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K043461.
How does its category compare?
All KDL devicesKDL Set, Perfusion, Kidney, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KDL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDL
Too few KDL 510(k)s in any year since 2007 to give a median.
Recalls per year · KDL
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KDL
1in 2025
MAUDE reports naming product code KDL, 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 | 7 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 30 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CUSTODIOL® HTK solution is indicated for perfusion and flushing of donor kidneys, liver, pancreas and heart 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 to the patient. CUSTODIOL® HTK solution is not indicated for continuous machine perfusion of donor organs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192408: Custodiol HTK Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192408
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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