510(k) · Cleared
ClearedPerfadex Solution for Lung Preservation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitrolife AB · MSB System And Accessories, Isolated Heart, Transport And Preservation
Cleared on Oct 27, 2003 as substantially equivalent to K000881 (Vitrolife Sweden AB, 2001) after a 437-day review. Its family tree reaches back 1 generation to 2001. 9 later devices descend from it.
- Decided
- Oct 27, 2003
- Review
- 437 days
- Class
- Class II
- Product code
- MSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000881 (2001). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000881 Perfadex Solution for Organ PreservationVitrolife Sweden AB · 2001
- This deviceK022730 Perfadex Solution for Lung PreservationVitrolife AB · 2003
- Descendant · cites it directly · 8 of its ownK081997 Perfadex with ThamVitrolife Sweden AB · 2008 · Recalled
- Descendant · 2 generations on · 7 of its ownK091989 Perfadex and Perfadex with ThamXvivo Perfusion AB · 2010
- Descendant · 3 generations on · 2 of its ownK170826 Perfadex PlusXvivo Perfusion AB · 2018
- Descendant · 3 generations on · 1 of its ownK240650 LungProtectTraferox Technologies, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK261644 Perfadex PlusXvivo Perfusion AB · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K081997Perfadex with ThamVitrolife Sweden AB · 2008 · cites it directly8descendants
- K091989Perfadex and Perfadex with ThamXvivo Perfusion AB · 2010 · 2 generations on7descendants
- K170826Perfadex PlusXvivo Perfusion AB · 2018 · 3 generations on2descendants
- K240650LungProtectTraferox Technologies, Inc. · 2024 · 3 generations on1descendant
- K261644Perfadex PlusXvivo Perfusion AB · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000881 | Perfadex Solution for Organ Preservation | Vitrolife Sweden AB | 2001 | — |
| 0 (this device) | K022730 | Perfadex Solution for Lung Preservation | Vitrolife AB | 2003 | — |
| +1 | K081997 | Perfadex with Tham | Vitrolife Sweden AB | 2008 | 1 |
| +2 | K091989 | Perfadex and Perfadex with Tham | Xvivo Perfusion AB | 2010 | — |
| +3 | K170826 | Perfadex Plus | Xvivo Perfusion AB | 2018 | — |
| +3 | K240650 | LungProtect | Traferox Technologies, Inc. | 2024 | — |
| +4 | K261644 | Perfadex Plus | Xvivo Perfusion AB | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K000881 | Perfadex Solution for Organ Preservation | 2001 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081997 | Perfadex with Tham | 2008 | 8 |
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?
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 | — |
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/K022730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022730: Perfadex Solution for Lung Preservation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022730
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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