510(k) · Cleared
ClearedBEL-GEN Cold Storage Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Georges Lopez · KDL Set, Perfusion, Kidney, Disposable
Cleared on Jun 14, 2022 as substantially equivalent to K121618 (Waters Medical Systems, LLC, 2013) and 1 other predicate after a 32-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Jun 14, 2022
- Review
- 32 days
- Class
- Class II
- Product code
- KDL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K944866 (1996). 5 ancestors in all. 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 deviceK221387 BEL-GEN Cold Storage SolutionInstitut Georges Lopez · 2022
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) | K221387 | BEL-GEN Cold Storage Solution | Institut Georges Lopez | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 KDL? 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 KDL device
- #1 K241239 OrganProtex HTK Solutionscore 9.9 · 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 |
|---|---|---|---|
| * | K121618 | Bel-Gen Cold Storage SolutionSummary page 4…Class II Product Code: KDL, KDN III. Predicate Device Identification Primary predicate: BEL-GEN Cold Storage Solution – Waters Instruments, Inc. – K121618 Secondary predicate: CoStorSol® - Preservation Solution Inc. – K091245 IV. Device Description Institut Georges Lopez manufac… | 2013 |
| * | K091245 | CostorsolSummary page 4…evice Identification Primary predicate: BEL-GEN Cold Storage Solution – Waters Instruments, Inc. – K121618 Secondary predicate: CoStorSol® - Preservation Solution Inc. – K091245 IV. Device Description Institut Georges Lopez manufactures the BEL-GEN Cold Storage Solution according to the solution pione… | 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 26 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- 2 of the 5 ancestors have a recall of any class.
How does its category compare?
All KDL devicesKDL Set, Perfusion, Kidney, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KDL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KDL
Too few KDL 510(k)s in any year since 2007 to give a median.
Recalls per year · KDL
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KDL
1in 2025
MAUDE reports naming product code KDL, 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 | 7 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 30 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BEL-GEN Cold Storage Solution is intended for the flushing and the hypothermic 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/K221387 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221387: BEL-GEN Cold Storage Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221387
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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