Therakos Development Limited
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Therakos Development Limited makes
Therakos Development Limited manufactures the UVAR XTS Procedural Kit, a device designed for extracorporeal photopheresis (ECP) therapy. This system is used to treat autoimmune and inflammatory skin conditions by exposing a patient’s white blood cells to ultraviolet light and reintroducing them into the body. The kit includes components necessary for the ECP procedure, including collection and processing bags, UV exposure chambers, and associated accessories.
The UVAR XTS Procedural Kit is classified as a Class III medical device under FDA regulations and requires Premarket Approval (PMA). It is listed in the FDA’s device registry, adhering to stringent requirements for high-risk devices. The company is based in the United States.
Catalogue
Uvar Xts Procedural Kit Ref P860003
Regimes: PMA Registry: PMA
FDA recalls
FDA recall records list 1 recall initiated by Therakos Development Limited, initiated on 2025-05-16. By recorded status: 1 ongoing. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 16 May 2025 Z-1822-2026 Class II Ongoing 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 delay in patient treatment and blood loss.
FDA establishments
- Therakos Development Limited Blanchardstown Dublin(County) · IE FEI 3036773437
Frequently asked questions
How many devices does Therakos Development Limited have in the registry?
The registry currently lists 1 device for Therakos Development Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Therakos Development Limited's devices?
Among its 1 most recently registered device, Therakos Development Limited has devices listed in FDA PMA (1 device).
What risk classes do Therakos Development Limited's devices fall under?
Among its 1 most recently registered device, the classes recorded for Therakos Development Limited's devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Therakos Development Limited?
FDA recall records list 1 recall initiated by Therakos Development Limited, the most recent initiated on 16 May 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Therakos Development Limited in the registry?
The most recently registered devices listed for Therakos Development Limited include UVAR XTS PROCEDURAL KIT.
Which FDA establishments are linked to Therakos Development Limited?
1 FDA establishment is linked to Therakos Development Limited in the registry; they are listed on the company page.