510(k) · Cleared
Recalled · 2011Perfadex with Tham
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 Oct 9, 2008 as substantially equivalent to K022730 (Vitrolife AB, 2003) after an 87-day review. Its family tree reaches back 2 generations to 2001. 8 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- MSB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000881 (2001). 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK000881 Perfadex Solution for Organ PreservationVitrolife Sweden AB · 2001
- 1 generation backK022730 Perfadex Solution for Lung PreservationVitrolife AB · 2003
- This deviceK081997 Perfadex with ThamVitrolife Sweden AB · 2008
- 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
- Descendant · 3 generations on · 0 of its ownK261644 Perfadex PlusXvivo Perfusion AB · 2026
- Descendant · 3 generations on · 0 of its ownK243870 X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- 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
- K261644Perfadex PlusXvivo Perfusion AB · 2026 · 3 generations on0descendants
- K243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000881 | Perfadex Solution for Organ Preservation | Vitrolife Sweden AB | 2001 | — |
| −1 | K022730 | Perfadex Solution for Lung Preservation | Vitrolife AB | 2003 | — |
| 0 (this device) | K081997 | Perfadex with Tham | Vitrolife Sweden AB | 2008 | — |
| +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 | — |
| +3 | K261644 | Perfadex Plus | Xvivo Perfusion AB | 2026 | — |
| +3 | K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K022730 | Perfadex Solution for Lung PreservationSummary page 1…Isolated kidney perfusion and transport system and accessories (21 C.F.R. § 876.5880) Predicate Device: Perfadex® (K022730) Description of the Device: Perfadex® with THAM is a colloid based "extracellular" low po… | 2003 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091989 | Perfadex and Perfadex with Tham | 2010 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2011 | Not classified | Z-2795-2011 | Process control | Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091989 (Xvivo Perfusion AB, 2010) has gone furthest, with 7 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. 2008, this device’s year, is highlighted.
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/K081997 · printed Nov 3, 2026
Cite this page
510(k) Report. “K081997: Perfadex with Tham.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K081997
Report an extraction error
Are you the manufacturer?
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