510(k) · Cleared
ClearedLow Potassium Dextran Solution with Tris Diluent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Therapeutics Corporation · KDN System, Perfusion, Kidney
Cleared on Feb 19, 2016 as substantially equivalent to K091989 (Xvivo Perfusion AB, 2010) after an 88-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Feb 19, 2016
- Review
- 88 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000881 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK000881 Perfadex Solution for Organ PreservationVitrolife Sweden AB · 2001
- 3 generations backK022730 Perfadex Solution for Lung PreservationVitrolife AB · 2003
- 2 generations backK081997 Perfadex with ThamVitrolife Sweden AB · 2008 · Recalled
- 1 generation backK091989 Perfadex and Perfadex with ThamXvivo Perfusion AB · 2010
- This deviceK153384 Low Potassium Dextran Solution with Tris DiluentUnited Therapeutics Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000881 | Perfadex Solution for Organ Preservation | Vitrolife Sweden AB | 2001 | — |
| −3 | K022730 | Perfadex Solution for Lung Preservation | Vitrolife AB | 2003 | — |
| −2 | K081997 | Perfadex with Tham | Vitrolife Sweden AB | 2008 | 1 |
| −1 | K091989 | Perfadex and Perfadex with Tham | Xvivo Perfusion AB | 2010 | — |
| 0 (this device) | K153384 | Low Potassium Dextran Solution with Tris Diluent | United Therapeutics Corporation | 2016 | — |
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 |
|---|---|---|---|
| * | K091989 | Perfadex and Perfadex with ThamSummary page 4…rfusion and transport system and accessories (21 CFR §876.5880) Regulatory Class: II Product Code: KDN III. PREDICATE DEVICE Perfadex® with THAM, K091989 IV. DEVICE DESCRIPTION Low Potassium Dextran (LPD) Solution is a sterile, clear, non-pyrogenic, physiological salt solution f… | 2010 |
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 15 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 3 other devices also cite its predicate K091989.
How does its category compare?
All KDN devicesKDN System, Perfusion, Kidney: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Low Potassium Dextran Solution with Tris Diluent is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153384: Low Potassium Dextran Solution with Tris Diluent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153384
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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