# K032372: Nucletron Comfort Catheter System, Model 189.007

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corporation
- Decided: Aug 15, 2003 after 14 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.
19 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020015: Implant Guidance System Applicator Set, Nucletron Corp. (2002)

## Most influential descendants
- K061241: Biolucent Applicator, Model Rta-XX (2006), 17 descendants of its own
- K070659: Biolucent Applicator Kit (2007), 13 descendants of its own
- K080565: Modification to: Savi Applicator Kit (2008), 12 descendants of its own
- K081677: Savi Applicator Kit (2008), 11 descendants of its own
- K091378: Mammosite II Radiation Therapy System (2009), 9 descendants of its own

## Indications for use
Comfort Catheter System is intended for interstitial Brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR.

Source page: https://510kreport.com/device/K032372
Methodology: https://510kreport.com/methodology