# K141701: I-125 RSLN [Radioactive Seed and Localization Needle]

- Pathway: 510(k) (Traditional)
- Applicant: Isoaid, LLC
- Decided: Dec 5, 2014 after 164 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.
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)
- K111979: Radioactive Seed Localization Needle, Biocompatibles, Inc. (2011) Summary page 4.

## Indications for use
The IsoAid RSLN is a device intended for the localization of suscipcious tissues (non-palpable lesions) for excision with the use of radioactive seeds.

Source page: https://510kreport.com/device/K141701
Methodology: https://510kreport.com/methodology