# K091117: Advantage-Strand/ Advantage-Load Brachytherapy Kit, Model Iaslbka

- Pathway: 510(k) (Traditional)
- Applicant: Isoaid, LLC
- Decided: Sep 15, 2009 after 151 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 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.

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

Source page: https://510kreport.com/device/K091117
Methodology: https://510kreport.com/methodology