510(k) · Cleared
ClearedPerfadex Plus
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 Jun 22, 2018 as substantially equivalent to K091989 (Xvivo Perfusion AB, 2010) after a 459-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.
- Decided
- Jun 22, 2018
- Review
- 459 days
- Class
- Class II
- Product code
- KDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000881 (2001). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK170826 Perfadex PlusXvivo Perfusion AB · 2018
- Descendant · cites it directly · 0 of its ownK261644 Perfadex PlusXvivo Perfusion AB · 2026
- Descendant · cites it directly · 0 of its ownK230193 Servator P Plus SALF SolutionS.A.L.F. Spa · 2023
Most influential descendants
Showing 2 of 2 · See allView 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) | K170826 | Perfadex Plus | Xvivo Perfusion AB | 2018 | — |
| +1 | K261644 | Perfadex Plus | Xvivo Perfusion AB | 2026 | — |
| +1 | K230193 | Servator P Plus SALF Solution | S.A.L.F. Spa | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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…REGULATION NUMBER 21 CFR §876.5880 CLASSIFICATION: Class II PRODUCT CODE KDN PREDICATE DEVICE: Perfadex® with THAM K091989 DESCRIPTION: Perfadex® Plus is a pre-buffered, extracellular solution of dextran 40 con… | 2010 |
What descends from it? (2)
2 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 17 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K261644 (Xvivo Perfusion AB, 2026) has gone furthest, with 0 descendants of its own.
- 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. 2018, 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 Plus is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K170826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170826: Perfadex Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170826
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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