510(k) · Cleared
ClearedCustodiol 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 Jan 6, 2003 as substantially equivalent to K944866 (The Dupont Merck Pharmaceutical Co., 1996) and 1 other predicate after a 291-day review. Its family tree reaches back 2 generations to 1996. 5 later devices descend from it.
- Decided
- Jan 6, 2003
- Review
- 291 days
- Class
- Class II
- Product code
- KDL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K944866 (1996). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- 1 generation backK992209 CustodiolDr. Franz Kohler Chemie GmbH · 1999
- This deviceK020924 Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2003
- Descendant · cites it directly · 4 of its ownK043461 CustodiolDr. Franz Kohler Chemie GmbH · 2005
- Descendant · 2 generations on · 1 of its ownK192408 Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2020 · Recalled
- Descendant · 3 generations on · 0 of its ownK241239 OrganProtex HTK SolutionBridge TO Life, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK170150 Servator H SALF solution-1000 ml PVC free bags, Servator H SALF…S.A.L.F. Spa · 2017
- Descendant · 2 generations on · 0 of its ownK143054 Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K043461CustodiolDr. Franz Kohler Chemie GmbH · 2005 · cites it directly4descendants
- K192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2020 · 2 generations on1descendant
- K241239OrganProtex HTK SolutionBridge TO Life, Ltd. · 2025 · 3 generations on0descendants
- K170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC…S.A.L.F. Spa · 2017 · 2 generations on0descendants
- K143054Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| −1 | K992209 | Custodiol | Dr. Franz Kohler Chemie GmbH | 1999 | — |
| 0 (this device) | K020924 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2003 | — |
| +1 | K043461 | Custodiol | Dr. Franz Kohler Chemie GmbH | 2005 | — |
| +2 | K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2020 | 1 |
| +3 | K241239 | OrganProtex HTK Solution | Bridge TO Life, Ltd. | 2025 | — |
| +2 | K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000… | S.A.L.F. Spa | 2017 | — |
| +2 | K143054 | Sherpa Pak Kidney Transport System | Paragonix Technologies, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K944866 | Viaspan (Belzer UW - CSS)Summary page 1…ETED PREDICATE DEVICES The Custodiol HTK Solution is substantially equivalent to the Viaspan Belzer UW Cold Storage Solution, which was cleared by FDA as K944866 on 04 April 1996, with respect to the indication for liver preservation. Custodiol is substantially equivalent to itself as… | 1996 |
| * | K992209 | CustodiolSummary page 1…d by FDA as K944866 on 04 April 1996, with respect to the indication for liver preservation. Custodiol is substantially equivalent to itself as cleared in K992209 in regard to physical and chemical characteristics. B. DEVICE DESCRIPTION The HTK solution is intended for perfusion and… | 1999 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043461 | Custodiol | 2005 | 4 |
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 7 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K043461 (Dr. Franz Kohler Chemie GmbH, 2005) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K944866.
How does its category compare?
All KDL devicesKDL Set, Perfusion, Kidney, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 donor kidneys and liver 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/K020924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020924: Custodiol HTK Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020924
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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