# K984446: `BI I-125 Brachytheraphy Seed, Model 125SL & 125SH

- Pathway: 510(k) (Traditional)
- Applicant: Urocor, Inc.
- Decided: Apr 16, 1999 after 123 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 K914281 (1991). 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)
- K914281: I-125 Seeds, Code: 6711, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1991) Summary page 1.

## Indications for use
MBI 1-125 Brachytherapy Seeds with apparent activities between 3.7 MBq (0.1 mCi) to 37 MBq (1.0 mCi) are indicated for permanent interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, slow growing, and exhibit low to moderate radiosensitivity. Intra abdominal, intrathoracic and superficial tumors may be treated with seeds containing apparent activities within this range. Tumors commonly treated are prostate (early stage), pancreas, head, neck, and lung. MBI I-125 Brachytherapy Seeds containing apparent activities greater than 37 MBq (1.0 mCi) are indicated for temporary interstitial treatment of tumors which are unresectable or residual after excision of the primary lesion, localized, and exhibit moderate radiosensitivity. Temporary implants are indicated in breast, brain and eye tumors. MBI I-125 Brachytherapy Seeds are indicated for treatment of residual tumors and recurrent tumors following external radiation therapy, hyperthermia, or chemotherapy or concurrent with these treatment modalities.

Source page: https://510kreport.com/device/K984446
Methodology: https://510kreport.com/methodology