# K090366: Spec Model M-31

- Pathway: 510(k) (Traditional)
- Applicant: Source Production & Equipment Co., Inc.
- Decided: Apr 22, 2009 after 68 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: 4 generations back to K914281 (1991). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 1.
- K042864: Implant Sciences Corp, Model HDR-4140, Implant Sciences Corp. (2005) Summary page 1.

## Most influential descendants
- K141038: Ant Model 1 (2014), 0 descendants of its own

## Indications for use
Source Production & Equipment Co., Inc. (SPEC) Model M-31 169Ytterbium 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. Model M-31 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/K090366
Methodology: https://510kreport.com/methodology