510(k) · Cleared
ClearedPerfadex Solution for Organ Preservation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitrolife Sweden AB · MSB System And Accessories, Isolated Heart, Transport And Preservation
Cleared on Mar 8, 2001 after a 353-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Mar 8, 2001
- Review
- 353 days
- Class
- Class II
- Product code
- MSB
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK000881 Perfadex Solution for Organ PreservationVitrolife Sweden AB · 2001
- Descendant · cites it directly · 9 of its ownK022730 Perfadex Solution for Lung PreservationVitrolife AB · 2003
- Descendant · 2 generations on · 8 of its ownK081997 Perfadex with ThamVitrolife Sweden AB · 2008 · Recalled
- Descendant · cites it directly · 7 of its ownK091989 Perfadex and Perfadex with ThamXvivo Perfusion AB · 2010
- Descendant · 2 generations on · 2 of its ownK170826 Perfadex PlusXvivo Perfusion AB · 2018
- Descendant · 2 generations on · 1 of its ownK240650 LungProtectTraferox Technologies, Inc. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K022730Perfadex Solution for Lung PreservationVitrolife AB · 2003 · cites it directly9descendants
- K081997Perfadex with ThamVitrolife Sweden AB · 2008 · 2 generations on8descendants
- K091989Perfadex and Perfadex with ThamXvivo Perfusion AB · 2010 · cites it directly7descendants
- K170826Perfadex PlusXvivo Perfusion AB · 2018 · 2 generations on2descendants
- K240650LungProtectTraferox Technologies, Inc. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000881 | Perfadex Solution for Organ Preservation | Vitrolife Sweden AB | 2001 | — |
| +1 | 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 | — |
| +2 | K170826 | Perfadex Plus | Xvivo Perfusion AB | 2018 | — |
| +2 | K240650 | LungProtect | Traferox Technologies, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSB? 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 MSB device
- #1 K261913 X°Port Heart Preservation Systemscore 13.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 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?
- Of its descendants, K022730 (Vitrolife AB, 2003) has gone furthest, with 9 descendants of its own.
How does its category compare?
All MSB devicesMSB System And Accessories, Isolated Heart, Transport And Preservation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MSB
Too few MSB 510(k)s in any year since 2007 to give a median.
Recalls per year · MSB
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSB
2in 2018
MAUDE reports naming product code MSB, 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 | 6 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K000881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000881: Perfadex Solution for Organ Preservation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000881
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026