510(k) · Cleared
Recalled · Class II · 2013Varisource Breast Template System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Oct 25, 2002 as substantially equivalent to K952913 (Varian Assoc., Inc., 1995) after a 28-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 25, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952913 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK952913 Applicators for Varian Varisource Remote High Soes Rate AfterloaderVarian Assoc., Inc. · 1995
- This deviceK023220 Varisource Breast Template SystemVarian Medical Systems · 2002
- Descendant · cites it directly · 0 of its ownK161540 Advanced Breast Template SystemVarian Medical Systems, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161540Advanced Breast Template SystemVarian Medical Systems, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952913 | Applicators for Varian Varisource Remote High Soes Rate Afterloader | Varian Assoc., Inc. | 1995 | — |
| 0 (this device) | K023220 | Varisource Breast Template System | Varian Medical Systems | 2002 | — |
| +1 | K161540 | Advanced Breast Template System | Varian Medical Systems, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K952913 | Applicators for Varian Varisource Remote High Soes Rate Afterloader | 1995 |
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 |
|---|---|---|---|
| K161540 | Advanced Breast Template System | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 9, 2013 | Class II | Z-0065-2014 | Nonconforming Material/Component | The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
The VariSource Breast Template System is indicated for high-dose rate Brachytherapy irradiation of the breast or chest wall. The system offers a means of performing interstitial implants with a futed geometry, for the treatment of breast carcinoma. A pair of a series of Templates are futed in place relative to one another with the Breast Bridge. The Breast Bridge is also used to hold the Templates over the breast during needle insertion and can be adjusted, via a ratchet mechanism to achieve the required template spacing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023220: Varisource Breast Template System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023220
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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