# K141038: Ant Model 1

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Nuclide Technologies, LLC
- Decided: Nov 12, 2014 after 204 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: 5 generations back to K914281 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994317: I-Plant, Model 3500, Implant Sciences Corp. (2000) Summary page 4.
- K090366: Spec Model M-31, Source Production & Equipment Co., Inc. (2009) Summary page 4.

## Indications for use
Advanced Nuclide Technologies LLC (ANT) Model 1 Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. ANT Model 1 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.

Source page: https://510kreport.com/device/K141038
Methodology: https://510kreport.com/methodology