PMA · Approved
Recalled · Class II · 2025Uvar Photopheresis System
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 Apr 8, 1987 through premarket approval, which rests on the device’s own clinical evidence after a 439-day review. It has been recalled 8 times.
- Decided
- Apr 8, 1987
- Review
- 439 days
- Class
- Class III
- Product code
- LNR
- Recalls
- 8
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P860003 has 107 supplements since 1987: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1987 | 4 |
| 1988 | 6 |
| 1989 | 2 |
| 1990 | 3 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 1 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 3 |
| 2005 | 1 |
| 2006 | 2 |
| 2008 | 3 |
| 2009 | 4 |
| 2010 | 1 |
| 2011 | 7 |
| 2012 | 5 |
| 2013 | 7 |
| 2014 | 2 |
| 2015 | 5 |
| 2016 | 5 |
| 2017 | 8 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 3 |
| 2025 | 3 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2025 | Class II | Z-1822-2026 | Process control | Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a… |
| Dec 10, 2021 | Class II | Z-0567-2022 | Under Investigation by firm | This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use. |
| Oct 4, 2021 | Class II | Z-0212-2022 | Under Investigation by firm | Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury. |
| Dec 21, 2015 | Class II | Z-1322-2016 | Nonconforming Material/Component | The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a portion of Kits from Lot D 342. |
| Sep 1, 2011 | Not classified | Z-0595-2012 | Other | There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System. |
| Feb 1, 2011 | Not classified | Z-2067-2011 | Process control | Therakos received an increased rate of complaints of centrifuge bowl leaks for certain lots of Therakos UVAR XTS Procedural Kits (Product Code XT 125). |
| Dec 2, 2010 | Not classified | Z-2839-2011 | Employee error | Cellex Procedural kits may have minor tears in their Tyvek covers. |
| Jul 18, 2006 | Not classified | Z-1504-06 | Other | Centrifuge Bowl may leak |
The 5 latest of 8 recalls; the web page lists all.
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.
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 · printed Nov 3, 2026
Cite this page
510(k) Report. “P860003: Uvar Photopheresis System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P860003
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026