510(k) · Cleared
ClearedUniversal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths
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 Aug 10, 2016 as substantially equivalent to K141490 (Varian Medical Systems, Inc., 2014) after a 168-day review. Its family tree reaches back 4 generations to 1991. 3 later devices descend from it.
- Decided
- Aug 10, 2016
- Review
- 168 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K912555 (1991). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK912555 Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 1991 · Recalled
- 3 generations backK983436 Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 1998 · Recalled
- 2 generations backK033371 Varian Intracavitary Brachytherapy ApplicatorsVarian Medical Systems · 2003 · Recalled
- 1 generation backK141490 Universal Segmented Cylinder Applicator Set and Universal Stump…Varian Medical Systems, Inc. · 2014
- This deviceK160516 Universal Cylinder Applicator Family, Universal Segmented Cylinder…Varian Medical Systems, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK172611 Universal Cylinder Applicator Family, Universal Segmented Cylinder…Varian Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK193240 Universal Cylinder Applicator FamilyVarian Medical Systems, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK252717 MAASTRO Rectal Applicator SetVarian Medical Systems · 2026
Most influential descendants
Showing 3 of 3 · See all- K172611Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set…Varian Medical Systems, Inc. · 2018 · cites it directly2descendants
- K193240Universal Cylinder Applicator FamilyVarian Medical Systems, Inc. · 2020 · 2 generations on1descendant
- K252717MAASTRO Rectal Applicator SetVarian Medical Systems · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912555 | Gammamed 12IT High Dose Rate Remote Afterloader | Rts Technology, Inc. | 1991 | 2 |
| −3 | K983436 | Gammamed Plus High Dose Rate Remote Afterloading System | Gammamed USA | 1998 | 17 |
| −2 | K033371 | Varian Intracavitary Brachytherapy Applicators | Varian Medical Systems | 2003 | 2 |
| −1 | K141490 | Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set | Varian Medical Systems, Inc. | 2014 | — |
| 0 (this device) | K160516 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator… | Varian Medical Systems, Inc. | 2016 | — |
| +1 | K172611 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator… | Varian Medical Systems, Inc. | 2018 | — |
| +2 | K193240 | Universal Cylinder Applicator Family | Varian Medical Systems, Inc. | 2020 | — |
| +3 | K252717 | MAASTRO Rectal Applicator Set | Varian Medical Systems | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K141490 | Universal Segmented Cylinder Applicator Set and Universal Stump Applicator SetSummary page 4…Applicator Set Universal Stump Applicator Set Universal Cervix Probe Sets Predicate Devices: K141490 Universal Cylinder Set. Device Description: The applicator sets in this submission are designed to be used with… | 2014 |
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 |
|---|---|---|---|
| K172611 | Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set… | 2018 | 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 4 companies; a new generation was cleared every 7.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K172611 (Varian Medical Systems, Inc., 2018) has gone furthest, with 2 descendants of its own.
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. 2016, 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 Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set are indicated for use for cancer treatment of the vagina, vaginal stump and rectum using HDR or PDR brachytherapy.
The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vagina, vaginal stump, cervix, uterus and endometrium using HDR or PDR 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/K160516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160516: Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160516
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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