510(k) · Cleared
ClearedTitanium Fletcher-Style Applicator Set-Defined Geometry
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 Jun 6, 2012 as substantially equivalent to K980590 (Varian Medical Systems, Inc., 1998) after an 89-day review. Its family tree reaches back 2 generations to 1987. 3 later devices descend from it.
- Decided
- Jun 6, 2012
- Review
- 89 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871217 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK871217 Henschke Afterloading ApplicatorMick Radio-Nuclear Instruments, Inc. · 1987
- 1 generation backK980590 Varisource Henschke Type Gyn Applicator for Varian Varisource Remote…Varian Medical Systems, Inc. · 1998
- This deviceK120731 Titanium Fletcher-Style Applicator Set-Defined GeometryVarian Medical Systems, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK241853 Titanium Fletcher-Style Applicator Set Defined Geometry; Smit…Varian Medical Systems, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK250299 CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243939 Titanium Flexible Geometry FSD Applicator Set (GM11013400)Varian Medical Systems, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K241853Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveVarian Medical Systems, Inc. · 2024 · cites it directly2descendants
- K250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc. · 2025 · 2 generations on0descendants
- K243939Titanium Flexible Geometry FSD Applicator Set (GM11013400)Varian Medical Systems, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871217 | Henschke Afterloading Applicator | Mick Radio-Nuclear Instruments, Inc. | 1987 | — |
| −1 | K980590 | Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose… | Varian Medical Systems, Inc. | 1998 | — |
| 0 (this device) | 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 | — |
| +2 | K250299 | CT/ MR Tandem and Ovoid Set | Varian Medical Systems, Inc. | 2025 | — |
| +2 | K243939 | Titanium Flexible Geometry FSD Applicator Set (GM11013400) | Varian Medical Systems, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K980590 | Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose Rate…Summary page 2…OFFEAThRE/SPECIFICATION - EW/MODIFIED DEIC Predicate Device Henschke Type GYN Applicator N/A Clearance Number: Set (980590 Compatible Afterloader Variource GammaMed plus… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241853 | Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve | 2024 | 2 |
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 25 years and passes through 2 companies; a new generation was cleared every 13.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241853 (Varian Medical Systems, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K980590.
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. 2012, 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 Titanium Fletcher-style Applicator Set with defined geometry was developed for brachytherapy treatment of cancer of the uterus, cervix, endometrium and vagina.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120731: Titanium Fletcher-Style Applicator Set-Defined Geometry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120731
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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