510(k) · Cleared
Recalled · Class II · 2018Costorsol
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 Jul 3, 2008 as substantially equivalent to K944866 (The Dupont Merck Pharmaceutical Co., 1996) after a 185-day review. Its family tree reaches back 1 generation to 1996. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 3, 2008
- Review
- 185 days
- Class
- Class II
- Product code
- KDN
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944866 (1996). 13 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- This deviceK073693 CostorsolPreservation Solutions, Inc. · 2008
- Descendant · cites it directly · 10 of its ownK083453 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 · cites it directly · 1 of its ownK191006 EasiSlushBridge TO Life, Ltd. · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK180194 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport…Paragonix Technologies, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K083453CostorsolPreservation Solutions, Inc. · 2009 · cites it directly10descendants
- K091245CostorsolPreservation Solutions, Inc. · 2009 · cites it directly8descendants
- K133694Sherpa Pak TransporterParagonix Technologies, Inc. · 2014 · 2 generations on3descendants
- K191006EasiSlushBridge TO Life, Ltd. · 2019 · cites it directly1descendant
- K180194SherpaPak Cardiac Transport System and SherpaPak Kidney Transport SystemParagonix Technologies, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| 0 (this device) | K073693 | Costorsol | Preservation Solutions, Inc. | 2008 | — |
| +1 | K083453 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| +1 | K091245 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| +2 | K133694 | Sherpa Pak Transporter | Paragonix Technologies, Inc. | 2014 | — |
| +1 | K191006 | EasiSlush | Bridge TO Life, Ltd. | 2019 | 1 |
| +3 | K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K944866 | Viaspan (Belzer UW - CSS)Summary page 1…ce Code: KDL IDENTIFICATION OF PREDICATE DEVICES CoStorSol® is a cold storage solution for harvested organs, which is substantially equivalent to a ViaSpan® solution (K944866). DEVICE DESCRIPTION Preservation Solutions, Inc. manufacturers CoStorSol® according to a "recipe" pioneered at t… | 1996 |
What descends from it? (13)
See all 135 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 26, 2018 | Class II | Z-1387-2018 | Nonconforming Material/Component | Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag.. |
| Sep 24, 2010 | Not classified | Z-0427-2011 | Labeling mix-ups | Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
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/K073693 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073693: Costorsol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073693
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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