# K113210: Advantage-Strand/Advantage-Load Brachytherapy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Isoaid, LLC
- Decided: Aug 10, 2012 after 283 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
Longest line of descent: 4 generations back to K801748 (1980). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040339: Brachytherapy Strand Device, Bebig Isotopen-Und Medizintechnik GmbH (2004) Summary page 1.
- K023210: Seedlinks, Models 70301, 70302, 70303, Sourcetech Medical, LLC (2003) Summary page 2.
- K012025: Macropore Surgiwrap (TS), Macropore Biosurgery, Inc. (2001) Summary page 1.

## Most influential descendants
- K242818: IsoSphere (2025), 0 descendants of its own

## Indications for use
The JsoAid Brachytherapy Kit is indicated for tumors that are localized, unreselectable, or have low to moderate radiosensitivity.

Source page: https://510kreport.com/device/K113210
Methodology: https://510kreport.com/methodology