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 · KDL Set, Perfusion, Kidney, Disposable
Cleared on Feb 28, 2005 as substantially equivalent to K944866 (The Dupont Merck Pharmaceutical Co., 1996) and 2 other predicates after a 75-day review. Its family tree reaches back 3 generations to 1996. 4 later devices descend from it.
- Decided
- Feb 28, 2005
- Review
- 75 days
- Class
- Class II
- Product code
- KDL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K944866 (1996). 4 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- 2 generations backK992209 CustodiolDr. Franz Kohler Chemie GmbH · 1999
- 1 generation backK020924 Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2003
- This deviceK043461 CustodiolDr. Franz Kohler Chemie GmbH · 2005
- Descendant · cites it directly · 1 of its ownK192408 Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK241239 OrganProtex HTK SolutionBridge TO Life, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK170150 Servator H SALF solution-1000 ml PVC free bags, Servator H SALF…S.A.L.F. Spa · 2017
- Descendant · cites it directly · 0 of its ownK143054 Sherpa Pak Kidney Transport SystemParagonix Technologies, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2020 · cites it directly1descendant
- K241239OrganProtex HTK SolutionBridge TO Life, Ltd. · 2025 · 2 generations on0descendants
- K170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC…S.A.L.F. Spa · 2017 · cites it directly0descendants
- K143054Sherpa Pak Kidney 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 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| −2 | K992209 | Custodiol | Dr. Franz Kohler Chemie GmbH | 1999 | — |
| −1 | K020924 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2003 | — |
| 0 (this device) | K043461 | Custodiol | Dr. Franz Kohler Chemie GmbH | 2005 | — |
| +1 | K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2020 | 1 |
| +2 | K241239 | OrganProtex HTK Solution | Bridge TO Life, Ltd. | 2025 | — |
| +1 | K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000… | S.A.L.F. Spa | 2017 | — |
| +1 | K143054 | Sherpa Pak Kidney Transport System | Paragonix Technologies, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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…ES For its indication for use, the Custodiol HTK Solution is substantially equivalent to the Belzer UW Cold Storage Solution, which was cleared by FDA as K944866 on 04 April 1 996 for the multiple indication of kidney, liver, and pancreas preservation. For its specific formulation and… | 1996 |
| * | K992209 | CustodiolSummary page 1…ecific formulation and other physical and chemical characteristics, it is substantially equivalent to the currently marketed Custodiol product as cleared under K992209 and K020924. B. DEVICE DESCRIPTION The HTK solution is intended for perfusion and flushing donor kidney, liver… | 1999 |
| * | K020924 | Custodiol HTK SolutionSummary page 1…n and other physical and chemical characteristics, it is substantially equivalent to the currently marketed Custodiol product as cleared under K992209 and K020924. B. DEVICE DESCRIPTION The HTK solution is intended for perfusion and flushing donor kidney, liver, heart, and panc… | 2003 |
What descends from it? (4)
3 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 9 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K192408 (Dr. Franz Kohler Chemie GmbH, 2020) has gone furthest, with 1 descendant 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, 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 (not for continuous perfusion) to the recipient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043461: Custodiol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043461
Report an extraction error
Are you the manufacturer?
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