# K991881: 125-Implant Seeds, Model STM1250

- Pathway: 510(k) (Traditional)
- Applicant: Sourcetech Medical, LLC
- Decided: Mar 16, 2000 after 288 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
I-125 Implant Seeds are indicated for permanent interstitial treatment of selected localized tumors such as head and neck, lung, pancreas and early stage prostate. I-125 Implant Seeds may be used in superficial, intra-abdominal or intra-thoracic locations. I-125 Implant Seeds may also be used in the treatment of residual tumors following completion of external beam radiation therapy and for other recurrent tumors.

Source page: https://510kreport.com/device/K991881
Methodology: https://510kreport.com/methodology