# K021343: Isoseeds I-125

- Pathway: 510(k) (Traditional)
- Applicant: Bebig Isotopen-Und Medizintechnik GmbH
- Decided: May 20, 2002 after 21 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: 2 generations back to K801748 (1980). 5 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982226: Uromed Brachytheraphy Iodine-125 Sources, Uromed Corp. (1999) Summary page 1.

## Most influential descendants
- K040339: Brachytherapy Strand Device (2004), 14 descendants of its own
- K043596: Theraload Custom Loaded Needles, Models 200 and 125.S06 (2005), 9 descendants of its own
- K062384: Cesium-131 Strand, Strand Preload, Preload, S-Cartridge (2006), 7 descendants of its own
- K092136: Proxcelan CS-131 Preloaded Braided Strands, Model: PL-5 (2009), 4 descendants of its own
- K180515: GammaTile (2018), 3 descendants of its own

## Indications for use
The BEBIG brachtherapy I-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 commeonly treated. They may be used alone, or in combination with external beam radiation.

Source page: https://510kreport.com/device/K021343
Methodology: https://510kreport.com/methodology