510(k) · Cleared
Recalled · 2008Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Source Production & Equipment Co., Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Apr 19, 2006 as substantially equivalent to K030745 (Varian Medical Systems, 2003) and 2 other predicates after a 181-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 19, 2006
- Review
- 181 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K864210 (1986). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 1 generation backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- This deviceK052947 Source Production & Equipment CO, Inc., Model M-19 IR-192…Source Production & Equipment Co., Inc. · 2006
- Descendant · cites it directly · 0 of its ownK092522 ACU007SOncology Systems, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K092522ACU007SOncology Systems, Inc. · 2009 · 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 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| 0 (this device) | K052947 | Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy Source | Source Production & Equipment Co., Inc. | 2006 | — |
| +1 | K092522 | ACU007S | Oncology Systems, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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 JAQ? 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 JAQ device
- #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K030745 | Gammamed 212 and 232 Source AssemblySummary page 1…Devices: Varian Medical Systems GammiaMed 232, cleared under 5 10(k) number K030745 dated 12 March 2003, and Nucletron Corp. Model 105.002, cleared under 5 10(lk) num… | 2003 |
| * | K953946 | Microselectron-HDR Version 2Summary page 1…rch 2003, and Nucletron Corp. Model 105.002, cleared under 5 10(lk) number K.953946 dated 13 August 1996, and Alpha-Omega Services, Inc. Model CSNOO IO- 192, cleared… | 1996 |
| * | K991571 | 10 Curie Irdium 192, CSN00100-192Summary page 1…Alpha-Omega Services, Inc. Model CSNOO IO- 192, cleared under 5 10(k) number K9915 71 dated 22 February 2000 (4) '9 ridium Brachytherapy Source: Description of SPE… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092522 | ACU007S | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2008 | Not classified | Z-1717-2009 | Other | Radioactive source broke during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K092522 (Oncology Systems, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K030745.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 2025
MAUDE reports naming product code JAQ, 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 | 11 | 48 | 0 | 13 |
| 2008 | 10 | 34 | 5 | 32 |
| 2009 | 10 | 27 | 1 | 35 |
| 2010 | 2 | — | 2 | 36 |
| 2011 | 2 | — | 13 | 42 |
| 2012 | 7 | 89 | 5 | 34 |
| 2013 | 6 | 100 | 1 | 43 |
| 2014 | 7 | 116 | 0 | 18 |
| 2015 | 11 | 183 | 0 | 7 |
| 2016 | 6 | 154 | 0 | 3 |
| 2017 | 7 | 229 | 0 | 5 |
| 2018 | 7 | 252 | 0 | 2 |
| 2019 | 2 | — | 1 | 8 |
| 2020 | 4 | 62 | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 10 | 126 | 0 | 1 |
| 2025 | 6 | 91 | 0 | 3 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
Source Production & Equipment Co., Inc. (SPEC) Model M-19 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This 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…
Read the full statement (101 words)
Source Production & Equipment Co., Inc. (SPEC) Model M-19 Source Assembly, with individual activity up to 12 Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This 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, hlng, 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/K052947 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052947: Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052947
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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