510(k) · Cleared
ClearedOCS Lung Donor Flush Set
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 Nov 18, 2022 as substantially equivalent to K203262 (Bridge TO Life, Ltd., 2021) after an 88-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Nov 18, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- MSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902394 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902394 | Resubmitted Multiorgan Perfusion Cannula | Fresenius USA, Inc. | 1990 | — |
| −1 | K203262 | Cannula for Organ Perfusion | Bridge TO Life, Ltd. | 2021 | — |
| 0 (this device) | K222535 | OCS Lung Donor Flush Set | TransMedics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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
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 |
|---|---|---|---|
| * | K203262 | Cannula for Organ PerfusionSummary page 4…MSB 3. PREDICATE DEVICE The subject device claims equivalence to the following legally marketed predicate device: 510(k) Number: K203262 Device Name: Cannula for Organ Perfusion Submitter: Bridge to Life Ltd. Regulation Name:… | 2021 |
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 30.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2022, 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?
The OCS™ Lung Donor Flush Set is a single-use device indicated for hypothermic flushing and replacement of residual
blood in donor lungs with a legally marketed organ preservation solution at the time of organ removal from the donor
during the preparation of these organs for transplantation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222535: OCS Lung Donor Flush Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222535
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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