510(k) · Cleared
ClearedPerfadex and Perfadex with Tham
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xvivo Perfusion AB · KDN System, Perfusion, Kidney
Cleared on Oct 1, 2010 as substantially equivalent to K000881 (Vitrolife Sweden AB, 2001) and 1 other predicate after a 456-day review. Its family tree reaches back 3 generations to 2001. 7 later devices descend from it.
- Decided
- Oct 1, 2010
- Review
- 456 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000881 (2001). 7 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK000881 Perfadex Solution for Organ PreservationVitrolife Sweden AB · 2001
- 2 generations backK022730 Perfadex Solution for Lung PreservationVitrolife AB · 2003
- 1 generation backK081997 Perfadex with ThamVitrolife Sweden AB · 2008 · Recalled
- This deviceK091989 Perfadex and Perfadex with ThamXvivo Perfusion AB · 2010
- Descendant · cites it directly · 2 of its ownK170826 Perfadex PlusXvivo Perfusion AB · 2018
- Descendant · cites it directly · 1 of its ownK240650 LungProtectTraferox Technologies, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK261644 Perfadex PlusXvivo Perfusion AB · 2026
- Descendant · 2 generations on · 0 of its ownK243870 X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK230193 Servator P Plus SALF SolutionS.A.L.F. Spa · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K170826Perfadex PlusXvivo Perfusion AB · 2018 · cites it directly2descendants
- K240650LungProtectTraferox Technologies, Inc. · 2024 · cites it directly1descendant
- K261644Perfadex PlusXvivo Perfusion AB · 2026 · 2 generations on0descendants
- K243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc. · 2025 · 2 generations on0descendants
- K230193Servator P Plus SALF SolutionS.A.L.F. Spa · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000881 | Perfadex Solution for Organ Preservation | Vitrolife Sweden AB | 2001 | — |
| −2 | K022730 | Perfadex Solution for Lung Preservation | Vitrolife AB | 2003 | — |
| −1 | K081997 | Perfadex with Tham | Vitrolife Sweden AB | 2008 | 1 |
| 0 (this device) | K091989 | Perfadex and Perfadex with Tham | Xvivo Perfusion AB | 2010 | — |
| +1 | K170826 | Perfadex Plus | Xvivo Perfusion AB | 2018 | — |
| +1 | K240650 | LungProtect | Traferox Technologies, Inc. | 2024 | — |
| +2 | K261644 | Perfadex Plus | Xvivo Perfusion AB | 2026 | — |
| +2 | K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. | 2025 | — |
| +2 | K230193 | Servator P Plus SALF Solution | S.A.L.F. Spa | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K000881 | Perfadex Solution for Organ PreservationSummary page 1…Isolated kidney perfusion and transport system and accessories (21 C.F.R. '.S76Z880)- Predicate Device: Perfadex® (K000881) and Perfadex® with THAM (K081 997) Description of the Device: Perfadex® and Perfadex® w~… | 2001 |
| * | K081997 | Perfadex with ThamSummary page 1…and accessories (21 C.F.R. '.S76Z880)- Predicate Device: Perfadex® (K000881) and Perfadex® with THAM (K081 997) Description of the Device: Perfadex® and Perfadex® w~xith THAM isa colloid based "extrac… | 2008 |
What descends from it? (7)
4 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)
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 9 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K170826 (Xvivo Perfusion AB, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K000881.
How does its category compare?
All KDN devicesKDN System, Perfusion, Kidney: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Perfadex® Solution for Lung Perfusion is indicated for the 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/K091989 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091989: Perfadex and Perfadex with Tham.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091989
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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