510(k) · Cleared
Recalled · 2012Viaspan (Belzer UW - CSS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Dupont Merck Pharmaceutical Co. · KDL Set, Perfusion, Kidney, Disposable
Cleared on Apr 22, 1996 after a 567-day review. The FDA summary names its predicate without a number. 20 later devices descend from it. It has been recalled once.
- Decided
- Apr 22, 1996
- Review
- 567 days
- Class
- Class II
- Product code
- KDL
- Recalls
- 1
- Predicates
- 0
20 later devices descend from it, 6 citing it directly.
- This deviceK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996
- Descendant · cites it directly · 13 of its ownK073693 CostorsolPreservation Solutions, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 10 of its ownK083453 CostorsolPreservation Solutions, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK091245 CostorsolPreservation Solutions, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK992209 CustodiolDr. Franz Kohler Chemie GmbH · 1999
- Descendant · cites it directly · 5 of its ownK020924 Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2003
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K073693CostorsolPreservation Solutions, Inc. · 2008 · cites it directly13descendants
- K083453CostorsolPreservation Solutions, Inc. · 2009 · 2 generations on10descendants
- K091245CostorsolPreservation Solutions, Inc. · 2009 · 2 generations on8descendants
- K992209CustodiolDr. Franz Kohler Chemie GmbH · 1999 · cites it directly6descendants
- K020924Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH · 2003 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | — |
| +1 | K073693 | Costorsol | Preservation Solutions, Inc. | 2008 | 2 |
| +2 | K083453 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| +2 | K091245 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| +1 | K992209 | Custodiol | Dr. Franz Kohler Chemie GmbH | 1999 | — |
| +1 | K020924 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Collins' solution Named without a submission number | |
| * | — | EuroCollins' solution Named without a submission number |
What descends from it? (20)
See all 206 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 30, 2012 | Not classified | Z-1437-2012 | Material/Component Contamination | Lack of assurance of sterility |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K073693 (Preservation Solutions, Inc., 2008) has gone furthest, with 13 descendants of its own.
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?
BELZER UW-CSS can be used for cold storage of the liver, pancreas, and kidney.
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/K944866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K944866: Viaspan (Belzer UW - CSS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K944866
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