# K033770: Isoaid Advantage PD-103, Model Iapd-103A

- Pathway: 510(k) (Traditional)
- Applicant: Isoaid, LLC
- Decided: Apr 8, 2004 after 127 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: 1 generation back to K010283 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010283: Theraseed (R) Palladium-103 Implant; Model 200, Theragenics Corp. (2001) Summary page 2.

## Indications for use
The IsoAid Palladium Brachytherapy Seed is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.

Source page: https://510kreport.com/device/K033770
Methodology: https://510kreport.com/methodology