510(k) Report

FDA applicant

Therakos Development Limited

Dublin1 decision1987–19878 recalls

FDA records 1 decision for Therakos Development Limited (Dublin) in 1987: 1 original PMA approval. All are in product code LNR (System, Photopheresis, Extracorporeal). 8 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Therakos Development Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Therakos Development Limited since 2007.

Recalls per year

1in 2025

2010: 12011: 22015: 12021: 22025: 1
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Therakos Development Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LNRSystem, Photopheresis, Extracorporeal1decision

What has FDA decided for it lately?

  • P860003Uvar Photopheresis SystemTherakos Development Limited · 19878 recalls

The one decision as Therakos Development Limited →

What has been recalled?

8 recalls linked to its devices; the latest:

  • P860003Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit…May 16, 2025Class II
  • P860003THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSADec 10, 2021Class II
  • P860003THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSAOct 4, 2021Class II
  • P860003The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA.…Dec 21, 2015Class II
  • P860003Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is…Sep 1, 2011
  • P860003Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA)…Feb 1, 2011