510(k) · Cleared
ClearedVarian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets
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 Sep 11, 2015 as substantially equivalent to K141624 (Varian Medical Systems, Inc., 2015) after a 52-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Sep 11, 2015
- Review
- 52 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 backK120341 Plastic Needle with Mandrin 2.0 Diameter Length 113MMVarian Medical Systems, Inc. · 2012
- 1 generation backK141624 Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt…Varian Medical Systems, Inc. · 2015
- This deviceK152018 Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop…Varian Medical Systems, Inc. · 2015
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 | K120341 | Plastic Needle with Mandrin 2.0 Diameter Length 113MM | Varian Medical Systems, Inc. | 2012 | — |
| −1 | K141624 | Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt Tip,Plastic Needle… | Varian Medical Systems, Inc. | 2015 | — |
| 0 (this device) | K152018 | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel… | Varian Medical Systems, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K141624 | Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt Tip,Plastic Needle with…Summary page 4…21 CFR 892.5700, Class II Product Code: JAQ III. Predicate Device: Plastic interstitial needles: K141624 IV. Device Description: The Cleaning Caps, the Leak Stop Buttons and Leak Stop Channel Marker… | 2015 |
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 28 years and passes through 2 companies; a new generation was cleared every 11.3 years on median.
- None of the 4 ancestors has a recall.
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. 2015, 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 Cleaning Cap is intended to close the lumens of applicator parts during the cleaning and disinfection process. New sterilized Cleaning Caps can be placed onto applicators during patient insertion if this is desired.
The Leak Stop Buttons are intended to prevent liquid entering the applicator or source guide tube connector during implantation and treatment. They are also used for fixation of the individual channel marker clips.
The Leak Stop Channel Marker Sets are intended for the individual numbering of the multiple channels in combination of avoiding liquid entering the applicator or source guide tube connectors.
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/K152018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152018: Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152018
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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