# K251037: Rectal Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron B.V.
- Decided: Dec 19, 2025 after 260 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: 3 generations back to K864210 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041715: Intracavitary Mould Applicator Set, Model 189.001, Nucletron Corp. (2005) Summary page 5.

## Indications for use
The Rectal Applicator is intended for brachytherapy for treatment of rectal and anal cancer in combination with Elekta HDR and PDR remote controlled afterloaders.

Source page: https://510kreport.com/device/K251037
Methodology: https://510kreport.com/methodology