510(k) · Cleared
ClearedEasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)
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 Jun 17, 2025 as substantially equivalent to K191006 (Bridge TO Life, Ltd., 2019) after a 207-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jun 17, 2025
- Review
- 207 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944866 (1996). No later device cites it as a predicate yet.
- 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 backK191006 EasiSlushBridge TO Life, Ltd. · 2019 · Recalled
- This deviceK243618 EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation…Bridge TO Life · 2025
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 | K191006 | EasiSlush | Bridge TO Life, Ltd. | 2019 | 1 |
| 0 (this device) | K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | 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 |
|---|---|---|---|
| * | K191006 | EasiSlushSummary page 6…0 PREDICATE DEVICE Company Device K Number Date Cleared Bridge to Life EasiSlush® K191006 Sept. 24, 2019 4.0 DEVICE DESCRIPTION EasiSlush® Sodium Chloride Solution for Sterile Slush Preparat… | 2019 |
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 4 companies; a new generation was cleared every 11.2 years on median.
- 3 of the 3 ancestors have a recall of any class.
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?
EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is intended for topical cooling of in situ, abdominal donor organs during intraoperative recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient. EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is used to establish, and maintain hypothermia of donor organs during recovery…
Read the full statement (346 words)
EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is intended for topical cooling of in situ, abdominal donor organs during intraoperative recovery from the donor. It is also intended to maintain organ hypothermia during storage and transport to the transplant recipient. EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.
It is also indicated for use during open surgical procedures such as cardiovascular, abdominal, and transplant surgeries.
Organ Recovery
Prior to organ recovery, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is delivered to the open peritoneal cavity of the donor to assist in creating hypothermia by topically cooling external surfaces of organs for recovery. During organ recovery, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional slushed solution may be delivered per established transplant team procedures. (Temperature rise may be assessed with temperature probes, being careful that the probe is measuring the solution and is not in contact with the organ).
Organ Storage/Transport
For organ storage/transport, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) may be used to topically cool external surfaces of a sterile, sealed, primary organ bag containing chilled preservation solution and the organ. In this application, the slushed solution may be added to a secondary bag or to a tertiary hard container to surround the primary organ bag. Once bagged, the organ can be placed in a bed of non-sterile ice in an insulated transport container, which is then closed. Actual use should follow standard practices of the OPO or hospital for transporting and storing specific types of donor organs using sterile, slush solutions.
Surgical Procedure
During surgical procedures, EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) is delivered to assist in creating hypothermia by topically cooling external surfaces of organs. During the procedure, if ice crystals are no longer visible, the temperature of the saline solution will begin to rise and additional slushed solution may be delivered per established surgical team procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243618: EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243618
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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