510(k) · Cleared
ClearedCT/ MR Tandem and Ovoid Set
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 May 9, 2025 as substantially equivalent to K241853 (Varian Medical Systems, Inc., 2024) after a 98-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- May 9, 2025
- Review
- 98 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871217 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK871217 Henschke Afterloading ApplicatorMick Radio-Nuclear Instruments, Inc. · 1987
- 3 generations backK980590 Varisource Henschke Type Gyn Applicator for Varian Varisource Remote…Varian Medical Systems, Inc. · 1998
- 2 generations backK120731 Titanium Fletcher-Style Applicator Set-Defined GeometryVarian Medical Systems, Inc. · 2012
- 1 generation backK241853 Titanium Fletcher-Style Applicator Set Defined Geometry; Smit…Varian Medical Systems, Inc. · 2024
- This deviceK250299 CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871217 | Henschke Afterloading Applicator | Mick Radio-Nuclear Instruments, Inc. | 1987 | — |
| −3 | K980590 | Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose… | Varian Medical Systems, Inc. | 1998 | — |
| −2 | K120731 | Titanium Fletcher-Style Applicator Set-Defined Geometry | Varian Medical Systems, Inc. | 2012 | — |
| −1 | K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | Varian Medical Systems, Inc. | 2024 | — |
| 0 (this device) | K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveSummary page 5…Regulation Number: §892.5700 Product Code: JAQ III. Predicate Device Titanium Fletcher-Style Applicator Set Defined Geometry (K241853) IV. Device Description The CT/MR Tandem and Ovoid Set is a gynecological brachytherapy applicator intended for use fo… | 2024 |
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 38 years and passes through 2 companies; a new generation was cleared every 12.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K241853.
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. 2025, this device’s year, is highlighted.
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 CT/MR Tandem and Ovoid Set is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR Brachytherapy.
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/K250299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250299: CT/ MR Tandem and Ovoid Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250299
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