510(k) · Cleared
ClearedBelzer-MPS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trans-Med Corp. · KDN System, Perfusion, Kidney
Cleared on Nov 26, 1997 after a 176-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Nov 26, 1997
- Review
- 176 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK972066 Belzer-MPSTrans-Med Corp. · 1997
- Descendant · cites it directly · 2 of its ownK121736 Perf-Gen Pulsatile Perfusion SolutionWaters Medical Systems, LLC · 2013
- Descendant · cites it directly · 1 of its ownK080432 MapersolPreservation Solutions, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK243840 Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)Bridge TO Life · 2025
- Descendant · 2 generations on · 0 of its ownK221386 PERF-GEN Pulsatile Perfusion SolutionInstitut Georges Lopez · 2022
- Descendant · 2 generations on · 0 of its ownK211842 Servator M SALF SolutionS.A.L.F. Spa · 2021
Most influential descendants
Showing 5 of 5 · See all- K121736Perf-Gen Pulsatile Perfusion SolutionWaters Medical Systems, LLC · 2013 · cites it directly2descendants
- K080432MapersolPreservation Solutions, Inc. · 2008 · cites it directly1descendant
- K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)Bridge TO Life · 2025 · 2 generations on0descendants
- K221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges Lopez · 2022 · 2 generations on0descendants
- K211842Servator M SALF SolutionS.A.L.F. Spa · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972066 | Belzer-MPS | Trans-Med Corp. | 1997 | — |
| +1 | K121736 | Perf-Gen Pulsatile Perfusion Solution | Waters Medical Systems, LLC | 2013 | — |
| +1 | K080432 | Mapersol | Preservation Solutions, Inc. | 2008 | — |
| +2 | K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life | 2025 | — |
| +2 | K221386 | PERF-GEN Pulsatile Perfusion Solution | Institut Georges Lopez | 2022 | — |
| +2 | K211842 | Servator M SALF Solution | S.A.L.F. Spa | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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?
- Of its descendants, K121736 (Waters Medical Systems, LLC, 2013) has gone furthest, with 2 descendants of its own.
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?
Belzer-MPS™ is the UW-gluconate perfusion solution indicated for the flushing and continuous hypothermic machine perfusion of donor kidneys.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972066: Belzer-MPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972066
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