510(k) · Cleared
ClearedMapersol
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Preservation Solutions, Inc. · KDN System, Perfusion, Kidney
Cleared on Aug 8, 2008 as substantially equivalent to K972066 (Trans-Med Corp., 1997) and 1 other predicate after a 171-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Aug 8, 2008
- Review
- 171 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013575 (2002). 3 ancestors in all, the oldest K972066 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK013575 KPS-I, the Kidney Perfusion SolutionOrgan Recovery Systems, Inc. · 2002
- 1 generation backK022391 Modification to KPS-1, Kidney Perfusion SolutiionOrgan Recovery Systems, Inc. · 2002
- This deviceK080432 MapersolPreservation Solutions, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK243840 Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)Bridge TO Life · 2025
Most influential descendants
Showing 1 of 1 · See all- K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)Bridge TO Life · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013575 | KPS-I, the Kidney Perfusion Solution | Organ Recovery Systems, Inc. | 2002 | — |
| −1 | K022391 | Modification to KPS-1, Kidney Perfusion Solutiion | Organ Recovery Systems, Inc. | 2002 | — |
| 0 (this device) | K080432 | Mapersol | Preservation Solutions, Inc. | 2008 | — |
| +1 | K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K972066 | Belzer-MPSSummary page 1…ICATE DEVICES MaPerSol® is a organ preservation solution for explanted kidneys, which is substantially equivalent to a both Belzer-MPSTM, UW Machine Perfusion Solution (K972066) and KPS-1 Kidney Perfusion Solution (K022391). DEVICE DESCRIPTION Preservation Solutions, Inc. manufacturers MaPerSoI® accordi… | 1997 |
| * | K022391 | Modification to KPS-1, Kidney Perfusion SolutiionSummary page 1…on solution for explanted kidneys, which is substantially equivalent to a both Belzer-MPSTM, UW Machine Perfusion Solution (K972066) and KPS-1 Kidney Perfusion Solution (K022391). DEVICE DESCRIPTION Preservation Solutions, Inc. manufacturers MaPerSoI® according to a "recipe" pioneered at the University o… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | 2025 | 0 |
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 6 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K243840 (Bridge TO Life, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K972066.
How does its category compare?
All KDN devicesKDN System, Perfusion, Kidney: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
MaPerSol® organ preservation solution is intended for in-vitro flushing and continuous
hypothermic machine perfusion of explanted kidneys.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080432 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080432: Mapersol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080432
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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