# K062830: Biolucent Applicator Kit

- Pathway: 510(k) (Special)
- Applicant: Biolucent, Inc.
- Decided: Oct 20, 2006 after 30 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
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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
- K121653: Intrabeam System with Intrabeam Spherical Applicators (2012), 8 descendants of its own

## Indications for use
The BioLucent Applicator Kit is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the BioLucent Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

Source page: https://510kreport.com/device/K062830
Methodology: https://510kreport.com/methodology