# K061241: Biolucent Applicator, Model Rta-XX

- Pathway: 510(k) (Traditional)
- Applicant: Biolucent, Inc.
- Decided: Jul 28, 2006 after 86 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: 4 generations back to K864210 (1986). 8 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980601: Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate Afterioader, Varian Assoc., Inc. (1998) Summary page 1.
- K032372: Nucletron Comfort Catheter System, Model 189.007, Nucletron Corporation (2003) Summary page 1.
- K961601: H.a.M. Applicator, Mick Radio-Nuclear Instruments, Inc. (1996) Summary page 1.
- (no number) NoviSad Rectal Applicator (Nucletron, B.V.): named in the summary without a submission number

## 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 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/K061241
Methodology: https://510kreport.com/methodology