PMA · Approved
ApprovedTHERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therakos Development Limited · LNR System, Photopheresis, Extracorporeal
Approved on Nov 21, 2025 through premarket approval, which rests on the device’s own clinical evidence after a 242-day review.
- Decided
- Nov 21, 2025
- Review
- 242 days
- Class
- Class III
- Product code
- LNR
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LNR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
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.
How does its category compare?
All LNR devicesLNR System, Photopheresis, Extracorporeal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · LNR
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNR
Too few LNR 510(k)s in any year since 2007 to give a median.
Recalls per year · LNR
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LNR
145in 2025
MAUDE reports naming product code LNR, 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 | 15 |
| 2008 | 3 | — | 0 | 8 |
| 2009 | 4 | — | 0 | 12 |
| 2010 | 1 | — | 2 | 36 |
| 2011 | 7 | — | 3 | 94 |
| 2012 | 5 | — | 0 | 120 |
| 2013 | 7 | — | 0 | 222 |
| 2014 | 2 | — | 0 | 377 |
| 2015 | 5 | — | 0 | 319 |
| 2016 | 5 | — | 0 | 318 |
| 2017 | 8 | — | 0 | 261 |
| 2018 | 4 | — | 0 | 183 |
| 2019 | 2 | — | 0 | 161 |
| 2020 | 1 | — | 0 | 141 |
| 2021 | 2 | — | 2 | 114 |
| 2022 | 3 | — | 0 | 97 |
| 2023 | 3 | — | 0 | 83 |
| 2024 | 0 | — | 0 | 151 |
| 2025 | 3 | — | 0 | 145 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P860003/S112 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860003/S112: THERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860003/S112
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026