# K242818: IsoSphere

- Pathway: 510(k) (Traditional)
- Applicant: Isoaid, LLC
- Decided: Jul 15, 2025 after 300 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: 5 generations back to K801748 (1980). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113210: Advantage-Strand/Advantage-Load Brachytherapy Kit, Isoaid, LLC (2012) Summary page 5.

## Indications for use
IsoSphere is indicated for implantation after tumor resection in the breast to deliver the prescribed radiation dose to the tumor bed and any residual tumor in the remaining margins.

Source page: https://510kreport.com/device/K242818
Methodology: https://510kreport.com/methodology