# K033781: Bebig Isoseed I-125

- Pathway: 510(k) (Special)
- Applicant: Bebig Isotopen-Und Medizintechnik GmbH
- Decided: Dec 30, 2003 after 26 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: 3 generations back to K801748 (1980). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021343: Isoseeds I-125, Bebig Isotopen-Und Medizintechnik GmbH (2002) Summary page 1.

## Most influential descendants
- K140849: Isoseed (2014), 0 descendants of its own

## Indications for use
The BEBIG brachtherapy 1-125 sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.

Source page: https://510kreport.com/device/K033781
Methodology: https://510kreport.com/methodology