510(k) · Cleared
ClearedSpec Model M15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Source Production & Equipment Co., Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Jan 2, 2014 as substantially equivalent to K991571 (Alpha-Omega Services, Inc., 2000) after a 101-day review. Its family tree reaches back 2 generations to 1986. 3 later devices descend from it.
- Decided
- Jan 2, 2014
- Review
- 101 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864210 (1986). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 1 generation backK991571 10 Curie Irdium 192, CSN00100-192Alpha-Omega Services, Inc. · 2000
- This deviceK132969 Spec Model M15Source Production & Equipment Co., Inc. · 2014
- Descendant · cites it directly · 0 of its ownK162573 Source Production & Equipment Co., Inc. Model M14 192Iridium…Source Production and Equipment Co., Inc. · 2016
- Descendant · cites it directly · 0 of its ownK161395 SPEC Model M13Source Production and Equipment Co., Inc. · 2016
- Descendant · cites it directly · 0 of its ownK150895 SPEC Model M16Source Production and Equipment Co., Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy SourceSource Production and Equipment Co., Inc. · 2016 · cites it directly0descendants
- K161395SPEC Model M13Source Production and Equipment Co., Inc. · 2016 · cites it directly0descendants
- K150895SPEC Model M16Source Production and Equipment Co., Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −1 | K991571 | 10 Curie Irdium 192, CSN00100-192 | Alpha-Omega Services, Inc. | 2000 | — |
| 0 (this device) | K132969 | Spec Model M15 | Source Production & Equipment Co., Inc. | 2014 | — |
| +1 | K162573 | Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy… | Source Production and Equipment Co., Inc. | 2016 | — |
| +1 | K161395 | SPEC Model M13 | Source Production and Equipment Co., Inc. | 2016 | — |
| +1 | K150895 | SPEC Model M16 | Source Production and Equipment Co., Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KXK device
- #1 K242818 IsoSpherescore 10.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991571 | 10 Curie Irdium 192, CSN00100-192Summary page 1…vice: Alpha-Omega Services, Inc. Model CSNOO1 0-1 92, cleared under 51 0(k) number K991 571 dated 22 February 2000 (4) Description of SPEC Model M15 11 2 ridium Brachytherapy Source: SPEC Model M15 is a si… | 2000 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 13.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162573 (Source Production and Equipment Co., Inc., 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K991571.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KXK
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KXK
158in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KXK
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KXK
7in 2025
MAUDE reports naming product code KXK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 42 | 0 | 9 |
| 2008 | 1 | — | 1 | 15 |
| 2009 | 7 | 63 | 0 | 10 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 94 | 1 | 35 |
| 2012 | 3 | 109 | 1 | 4 |
| 2013 | 3 | 127 | 0 | 29 |
| 2014 | 8 | 96 | 0 | 13 |
| 2015 | 2 | — | 0 | 6 |
| 2016 | 4 | 49 | 1 | 40 |
| 2017 | 2 | — | 0 | 41 |
| 2018 | 1 | — | 0 | 28 |
| 2019 | 2 | — | 0 | 10 |
| 2020 | 3 | 158 | 0 | 15 |
| 2021 | 0 | — | 0 | 62 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (131 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132969 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132969: Spec Model M15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132969
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026