510(k) · Cleared
ClearedVarian Endometrial Applicator for Varisource Remote High Dose Rate Afterloader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Nov 2, 1998 as substantially equivalent to K871216 (Mick Radio-Nuclear Instruments, Inc., 1987) after a 258-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it.
- Decided
- Nov 2, 1998
- Review
- 258 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K871216 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK871216 Hilaris-Nori Endometrial ApplicatorMick Radio-Nuclear Instruments, Inc. · 1987
- This deviceK980576 Varian Endometrial Applicator for Varisource Remote High Dose Rate…Varian Medical Systems, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK232623 Universal Endometrial Applicator Set (GM11009840)Varian Medical Systems, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK160021 Varian Sterilization BoxesVarian Medical Systems, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871216 | Hilaris-Nori Endometrial Applicator | Mick Radio-Nuclear Instruments, Inc. | 1987 | — |
| 0 (this device) | K980576 | Varian Endometrial Applicator for Varisource Remote High Dose Rate Afterloader | Varian Medical Systems, Inc. | 1998 | — |
| +1 | K232623 | Universal Endometrial Applicator Set (GM11009840) | Varian Medical Systems, Inc. | 2024 | — |
| +1 | K160021 | Varian Sterilization Boxes | Varian Medical Systems, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K871216 | Hilaris-Nori Endometrial ApplicatorSummary page 1…VariSource Endometrial Applicator for Varian VariSource™ Remote High Dose Rate Afterloader. Mick Radio-Nuclear Instruments, Inc., Hilaris-Nori Endometrial Applicator, K871216. Applicators for the Varian VariSource Remote High Dose Rate Afterloader are a part of a remote controlled radionuclide applicat… | 1987 |
What descends from it? (2)
2 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?
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 Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Endometrial applicator which is the subject of this 510(k) is a component of the VariSource system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980576: Varian Endometrial Applicator for Varisource Remote High Dose Rate Afterloader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980576
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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