# K161395: SPEC Model M13

- Pathway: 510(k) (Traditional)
- Applicant: Source Production and Equipment Co., Inc.
- Decided: Jul 6, 2016 after 48 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: 3 generations back to K864210 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132969: Spec Model M15, Source Production & Equipment Co., Inc. (2014) Summary page 4.

## Indications for use
The intended use of Source Production & Equipment Co., Inc. Model M13 192Iridium Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

Source page: https://510kreport.com/device/K161395
Methodology: https://510kreport.com/methodology