510(k) · Cleared
ClearedBelzer UW® Cold Storage Solution (BTLBUW-001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bridge TO Life · KDN System, Perfusion, Kidney
Cleared on Mar 31, 2025 as substantially equivalent to K091245 (Preservation Solutions, Inc., 2009) after a 151-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Mar 31, 2025
- Review
- 151 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944866 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK944866 Viaspan (Belzer UW - CSS)The Dupont Merck Pharmaceutical Co. · 1996 · Recalled
- 3 generations backK073693 CostorsolPreservation Solutions, Inc. · 2008 · Recalled
- 2 generations backK083453 CostorsolPreservation Solutions, Inc. · 2009
- 1 generation backK091245 CostorsolPreservation Solutions, Inc. · 2009
- This deviceK243384 Belzer UW® Cold Storage Solution (BTLBUW-001)Bridge TO Life · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944866 | Viaspan (Belzer UW - CSS) | The Dupont Merck Pharmaceutical Co. | 1996 | 1 |
| −3 | K073693 | Costorsol | Preservation Solutions, Inc. | 2008 | 2 |
| −2 | K083453 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| −1 | K091245 | Costorsol | Preservation Solutions, Inc. | 2009 | — |
| 0 (this device) | K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life | 2025 | — |
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 |
|---|---|---|---|
| * | K091245 | CostorsolSummary page 5…Company Device K Number Date Cleared Preservation Solutions, Inc CoStorSol® Solution K091245 June 17, 2009 4.0 DEVICE DESCRIPTION Belzer UW® Cold Storage Solution (BTLBUW-001) is a clear to li… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 5 other devices also cite its predicate K091245.
How does its category compare?
All KDN devicesKDN System, Perfusion, Kidney: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Belzer UW® Cold Storage Solution (BTLBUW-001) is indicated 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. Belzer UW® Cold Storage Solution (BTLBUW-001) is not indicated for continuous machine perfusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243384 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243384: Belzer UW® Cold Storage Solution (BTLBUW-001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243384
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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