# K262383: LumenCare Azure

- Pathway: 510(k) (Special)
- Applicant: Nucletron B.V.
- Decided: Jul 24, 2026 after 11 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K132874 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132874: Lumencare Azure Set F6, 150CM, Lumecare Azure Set 5F, 150 CM, Lumencare Azure Set 5F, 140 CM, Nucletron B.V. (2014) Summary page 5.

## Indications for use
The LumenCare Azure is intended for intraluminal brachytherapy and is used for treatment of the lung or other lumen, e.g. bronchus and bile duct. The LumenCare Azure is designed to fit in the working channel of an endoscope.

Source page: https://510kreport.com/device/K262383
Methodology: https://510kreport.com/methodology