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 Jan 21, 2009 as substantially equivalent to K073693 (Preservation Solutions, Inc., 2008) after a 61-day review. Its family tree reaches back 2 generations to 1996. 10 later devices descend from it.
- Decided
- Jan 21, 2009
- Review
- 61 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944866 (1996). 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- 1 generation backK073693 CostorsolPreservation Solutions, Inc. · 2008 · Recalled
- This deviceK083453 CostorsolPreservation Solutions, Inc. · 2009
- Descendant · cites it directly · 8 of its ownK091245 CostorsolPreservation Solutions, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK133694 Sherpa Pak TransporterParagonix Technologies, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK180194 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport…Paragonix Technologies, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK091656 SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L…Organ Recovery Systems, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 0 of its ownK261913 X°Port Heart Preservation SystemTraferox Technologies, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K091245CostorsolPreservation Solutions, Inc. · 2009 · cites it directly8descendants
- K133694Sherpa Pak TransporterParagonix Technologies, Inc. · 2014 · 2 generations on3descendants
- K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. · 2018 · 3 generations on1descendant
- K091656SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2LOrgan Recovery Systems, Inc. · 2010 · cites it directly1descendant
- K261913X°Port Heart Preservation SystemTraferox Technologies, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| −1 | K073693 | Costorsol | Preservation Solutions, Inc. | 2008 | 2 |
| 0 (this device) | K083453 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| +1 | K091245 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| +2 | K133694 | Sherpa Pak Transporter | Paragonix Technologies, Inc. | 2014 | — |
| +3 | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018 | — |
| +1 | K091656 | SPS-1TM Static Preservation Solution, Models SPS-1-500 ML, SPS 1-1L, SPS-1-2L | Organ Recovery Systems, Inc. | 2010 | 1 |
| +4 | K261913 | X°Port Heart Preservation System | Traferox Technologies, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K073693 | CostorsolSummary page 1…re, is a transplant graft storage solution for harvested organs, which issubstantially equivalent to the original CoStorSol® solution cleared to market under 51 0(k) K073693 DEVICE DESCRIPTION Preservation Solutions, Inc manufacturers CoStorSol® according to a 'recipe" pioneered at the Universi… | 2008 |
What descends from it? (10)
3 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 12.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K091245 (Preservation Solutions, Inc., 2009) has gone furthest, with 8 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/K083453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083453: Costorsol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083453
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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