510(k) · Cleared
ClearedOCS Lung Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TransMedics, Inc. · MSB System And Accessories, Isolated Heart, Transport And Preservation
Cleared on Jul 29, 2021 as substantially equivalent to K000881 (Vitrolife Sweden AB, 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 29, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- MSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000881 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK000881 Perfadex Solution for Organ PreservationVitrolife Sweden AB · 2001
- This deviceK211314 OCS Lung SolutionTransMedics, Inc. · 2021
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) | K211314 | OCS Lung Solution | TransMedics, Inc. | 2021 | — |
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
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 PreservationSummary page 4…MSB 3. PREDICATE DEVICE The subject device claims equivalence to the following legally marketed predicate device: 510(k) Number: K000881 Device Name: Perfadex® Submitter: VitroLife Sweden AB (now distributed by the subsidiary Xvivo… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K000881.
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. 2021, 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?
OCS™ Lung Solution is intended for 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/K211314 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211314: OCS Lung Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211314
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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