# K982226: Uromed Brachytheraphy Iodine-125 Sources

- Pathway: 510(k) (Traditional)
- Applicant: Uromed Corp.
- Decided: May 13, 1999 after 323 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 K801748 (1980). 4 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801748: 3M I-125 Seeds in Absorbable Carrier, 3M Company (1980) Summary page 1.
- K972271: North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-a, Ml Strategies, Inc. (1997) Summary page 1.
- K964647: North American Scientific (Nasi) 1-125 Radionuclide Brachytherapy Source, North American Scientific, Inc. (1997) Summary page 1.
- K874787: Modified Palladium Seed Model 100, Theragenics Corp. (1987) Summary page 1.

## Most influential descendants
- K021343: Isoseeds I-125 (2002), 18 descendants of its own
- 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

## Indications for use
The UroMed I-125 Radionuclide Brachytherapy 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/K982226
Methodology: https://510kreport.com/methodology