510(k) · Cleared
ClearedSPEC Model M13
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Source Production and Equipment Co., Inc. · KXK Source, Brachytherapy, Radionuclide
Cleared on Jul 6, 2016 as substantially equivalent to K132969 (Source Production & Equipment Co., Inc., 2014) after a 48-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jul 6, 2016
- Review
- 48 days
- Class
- Class II
- Product code
- KXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864210 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 2 generations backK991571 10 Curie Irdium 192, CSN00100-192Alpha-Omega Services, Inc. · 2000
- 1 generation backK132969 Spec Model M15Source Production & Equipment Co., Inc. · 2014
- This deviceK161395 SPEC Model M13Source Production and Equipment Co., Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −2 | K991571 | 10 Curie Irdium 192, CSN00100-192 | Alpha-Omega Services, Inc. | 2000 | — |
| −1 | K132969 | Spec Model M15 | Source Production & Equipment Co., Inc. | 2014 | — |
| 0 (this device) | K161395 | SPEC Model M13 | Source Production and Equipment Co., Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K132969 | Spec Model M15Summary page 4…Device: Source Production & Equipment Co., Inc. Model M15, cleared under 510(k) number K132969 dated 02 January 2014 (4) Description of Source Production & Equipment Co., Inc. M… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 4 companies; a new generation was cleared every 13.2 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K132969.
How does its category compare?
All KXK devicesKXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161395: SPEC Model M13.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161395
Report an extraction error
Are you the manufacturer?
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