# K132969: Spec Model M15

- Pathway: 510(k) (Traditional)
- Applicant: Source Production & Equipment Co., Inc.
- Decided: Jan 2, 2014 after 101 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: 2 generations back to K864210 (1986). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991571: 10 Curie Irdium 192, CSN00100-192, Alpha-Omega Services, Inc. (2000) Summary page 1.

## Most influential descendants
- K162573: Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source (2016), 0 descendants of its own
- K161395: SPEC Model M13 (2016), 0 descendants of its own
- K150895: SPEC Model M16 (2015), 0 descendants of its own

## Indications for use
The Source Production & Equipment Co., Inc. (SPEC) Model M 15 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary. intraluminal, intraoperative or surface application to treat selected localized tumors. This source is designed for use in medical brachytherapy applications and may only be used in conjunction with the Nucletron microSelectron Classic High Dose Rate Remote Afterloader. The Model MI5 source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with external beam radiation therapy.

Source page: https://510kreport.com/device/K132969
Methodology: https://510kreport.com/methodology