# K041715: Intracavitary Mould Applicator Set, Model 189.001

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: Mar 24, 2005 after 274 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: 2 generations back to K864210 (1986). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953946: Microselectron-HDR Version 2, Nucletron-Oldelft Corp. (1996) Summary page 3.

## Most influential descendants
- K251037: Rectal Applicator (2025), 0 descendants of its own

## Indications for use
The Intracavitary Mould Applicator Set is intended for use with Nucletron remote afterloading equipment for intracavitary rectal brachytherapy procedures. The applicator set provides a means of delivering the prescribed radiation dose to the treatment area.

Source page: https://510kreport.com/device/K041715
Methodology: https://510kreport.com/methodology