# K163206: SMD-Sr90-DA Radionuclide Brachytherapy Source

- Pathway: 510(k) (Traditional)
- Applicant: Salutaris Medical Devices, Inc.
- Decided: Dec 15, 2016 after 30 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The SMD-Sr90-DA Radionuclide Brachytherapy Source (RBS) device is indicated for episcleral brachytherapy. The SMD-Sr90-DA RBS device is intended for use within a manual brachytherapy applicator system.

Source page: https://510kreport.com/device/K163206
Methodology: https://510kreport.com/methodology