510(k) · Cleared
ClearedKPS-I, the Kidney Perfusion Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Organ Recovery Systems, Inc. · KDN System, Perfusion, Kidney
Cleared on Jan 25, 2002 after an 88-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jan 25, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK013575 KPS-I, the Kidney Perfusion SolutionOrgan Recovery Systems, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK022391 Modification to KPS-1, Kidney Perfusion SolutiionOrgan Recovery Systems, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK080432 MapersolPreservation Solutions, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK243840 Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)Bridge TO Life · 2025
Most influential descendants
Showing 3 of 3 · See all- K022391Modification to KPS-1, Kidney Perfusion SolutiionOrgan Recovery Systems, Inc. · 2002 · cites it directly2descendants
- K080432MapersolPreservation Solutions, Inc. · 2008 · 2 generations on1descendant
- K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)Bridge TO Life · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K080432 | Mapersol | Preservation Solutions, Inc. | 2008 | — |
| +3 | K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | — | Belzer MPS™ (UW Kidney Preservation Solution) Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022391 | Modification to KPS-1, Kidney Perfusion Solutiion | 2002 | 2 |
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, K022391 (Organ Recovery Systems, Inc., 2002) 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?
KPS-I™ The Kidney Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a 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/K013575 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013575: KPS-I, the Kidney Perfusion Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013575
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026