# K080565: Modification to: Savi Applicator Kit

- Pathway: 510(k) (Special)
- Applicant: Cianna Medical, Inc.
- Decided: Apr 4, 2008 after 35 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: 6 generations back to K864210 (1986). 14 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062830: Biolucent Applicator Kit, Biolucent, Inc. (2006) Summary page 1.
- K061241: Biolucent Applicator, Model Rta-XX, Biolucent, Inc. (2006) Summary page 1.
- K070659: Biolucent Applicator Kit, Biolucent, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K133655: Radiance V2 (2014), 5 descendants of its own
- K153368: Radiance V3 (2016), 4 descendants of its own

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

Source page: https://510kreport.com/device/K080565
Methodology: https://510kreport.com/methodology