510(k) · Cleared
ClearedCostorsol
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 Jun 17, 2009 as substantially equivalent to K073693 (Preservation Solutions, Inc., 2008) and 1 other predicate after a 50-day review. Its family tree reaches back 3 generations to 1996. 8 later devices descend from it.
- Decided
- Jun 17, 2009
- Review
- 50 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K944866 (1996). 8 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- 2 generations backK073693 CostorsolPreservation Solutions, Inc. · 2008 · Recalled
- 1 generation backK083453 CostorsolPreservation Solutions, Inc. · 2009
- This deviceK091245 CostorsolPreservation Solutions, Inc. · 2009
- Descendant · cites it directly · 3 of its ownK133694 Sherpa Pak TransporterParagonix Technologies, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK180194 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport…Paragonix Technologies, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK261913 X°Port Heart Preservation SystemTraferox Technologies, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243384 Belzer UW® Cold Storage Solution (BTLBUW-001)Bridge TO Life · 2025
- Descendant · cites it directly · 0 of its ownK221387 BEL-GEN Cold Storage SolutionInstitut Georges Lopez · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K133694Sherpa Pak TransporterParagonix Technologies, Inc. · 2014 · cites it directly3descendants
- K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. · 2018 · 2 generations on1descendant
- K261913X°Port Heart Preservation SystemTraferox Technologies, Inc. · 2026 · 3 generations on0descendants
- K243384Belzer UW® Cold Storage Solution (BTLBUW-001)Bridge TO Life · 2025 · cites it directly0descendants
- K221387BEL-GEN Cold Storage SolutionInstitut Georges Lopez · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| −2 | K073693 | Costorsol | Preservation Solutions, Inc. | 2008 | 2 |
| −1 | K083453 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| 0 (this device) | K091245 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| +1 | K133694 | Sherpa Pak Transporter | Paragonix Technologies, Inc. | 2014 | — |
| +2 | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018 | — |
| +3 | K261913 | X°Port Heart Preservation System | Traferox Technologies, Inc. | 2026 | — |
| +1 | K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life | 2025 | — |
| +1 | K221387 | BEL-GEN Cold Storage Solution | Institut Georges Lopez | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 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 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 |
|---|---|---|---|
| * | K073693 | CostorsolSummary page 1…splant graft storage solution for harvested organs, which is substantially equivalent to the original CoStorSol® solution cleared to market under premarket notifications K073693 and K083453. DEVICE DESCRIPTION Preservation Solutions, Inc. manufacturers CoStorSol® according to a "recipe" pioneered at the… | 2008 |
| * | K083453 | CostorsolSummary page 1…storage solution for harvested organs, which is substantially equivalent to the original CoStorSol® solution cleared to market under premarket notifications K073693 and K083453. DEVICE DESCRIPTION Preservation Solutions, Inc. manufacturers CoStorSol® according to a "recipe" pioneered at the University… | 2009 |
What descends from it? (8)
6 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 7 months on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K133694 (Paragonix Technologies, Inc., 2014) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K073693.
How does its category compare?
All KDN devicesKDN System, Perfusion, Kidney: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ 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/K091245 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091245: Costorsol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091245
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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