# K122704: Best Localization Needle with I-125 Seed

- Pathway: 510(k) (Traditional)
- Applicant: Best Medical Intl.
- Decided: Jan 9, 2013 after 127 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 K111979 (2011). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111979: Radioactive Seed Localization Needle, Biocompatibles, Inc. (2011) Summary page 1.

## Most influential descendants
- K142668: Lesion-Loc Iodine I-125 Seed/Needle (2014), 0 descendants of its own

## Indications for use
The device is indicated as "single-use sterile device". Best Localization Needle with I-125 Seed is indicated in the use for Breast Localization purpose under the direct supervision of a qualified physician.

Source page: https://510kreport.com/device/K122704
Methodology: https://510kreport.com/methodology