510(k) · Cleared
ClearedModification to KPS-1, Kidney Perfusion Solutiion
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 Oct 21, 2002 as substantially equivalent to K013575 (Organ Recovery Systems, Inc., 2002) after a 90-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Oct 21, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013575 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK013575 KPS-I, the Kidney Perfusion SolutionOrgan Recovery Systems, Inc. · 2002
- This deviceK022391 Modification to KPS-1, Kidney Perfusion SolutiionOrgan Recovery Systems, Inc. · 2002
- 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013575 | KPS-I, the Kidney Perfusion Solution | Organ Recovery Systems, Inc. | 2002 | — |
| 0 (this device) | K022391 | Modification to KPS-1, Kidney Perfusion Solutiion | Organ Recovery Systems, Inc. | 2002 | — |
| +1 | K080432 | Mapersol | Preservation Solutions, Inc. | 2008 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K013575 | KPS-I, the Kidney Perfusion SolutionSummary page 3…al Characteristics: Unchanged f b m Original Submissiorz 5. CONCLUSXON KPS-lW, The Kidney P h i o n Solution has the same intended w e as the original submission (K013575)and the data presented inthis submksion demonstrates that the device modificationsto KPS-lm, The Kidney Perfusion Solution is… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080432 | Mapersol | 2008 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K080432 (Preservation Solutions, Inc., 2008) has gone furthest, with 1 descendant 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-1™, 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 as stated in the FDA summary.
https://510kreport.com/device/K022391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022391: Modification to KPS-1, Kidney Perfusion Solutiion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022391
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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