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 · KDN System, Perfusion, Kidney
Cleared on Dec 10, 1999 as substantially equivalent to K944866 (The Dupont Merck Pharmaceutical Co., 1996) after a 163-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.
- Decided
- Dec 10, 1999
- Review
- 163 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944866 (1996). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- This deviceK992209 CustodiolDr. Franz Kohler Chemie GmbH · 1999
- Descendant · cites it directly · 5 of its ownK020924 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K020924Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2003 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| 0 (this device) | K992209 | Custodiol | Dr. Franz Kohler Chemie GmbH | 1999 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 KDN? 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 KDN device
- #1 K261644 Perfadex Plusscore 12.9 · 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 |
|---|---|---|---|
| * | K944866 | Viaspan (Belzer UW - CSS)Summary page 1…A. LEGALLY MARKETED 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. B. DEVICE DESCRIPTION The HTK solution is intended for perfusion and flushing donor kidneys prior to removal… | 1996 |
What descends from it? (6)
2 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?
How does its category compare?
All KDN devicesKDN System, Perfusion, Kidney: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDN
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDN
135in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KDN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KDN
3in 2025
MAUDE reports naming product code KDN, 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 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 2 | — | 0 | 9 |
| 2021 | 3 | 238 | 0 | 1 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 5 | 135 | 0 | 3 |
| 2026 | 3 | 66 | 1 | — |
What is it indicated for?
Custodiol HTK Solution is indicated for perfusion and flushing donor kidneys 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992209 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992209: Custodiol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992209
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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