# K011155: Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031S

- Pathway: 510(k) (Abbreviated)
- Applicant: Ibt, Inc.
- Decided: Jul 12, 2001 after 87 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.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041702: EZ-Pak (EZ-Pak IS a Trademark of Ibt S.a.) (2004), 8 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
- K190296: GammaTile (2019), 2 descendants of its own

Source page: https://510kreport.com/device/K011155
Methodology: https://510kreport.com/methodology