510(k) · Cleared
ClearedPlastic Needle with Mandrin 2.0 Diameter Length 113MM
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 Apr 27, 2012 as substantially equivalent to K980590 (Varian Medical Systems, Inc., 1998) after an 84-day review. Its family tree reaches back 2 generations to 1987. 2 later devices descend from it.
- Decided
- Apr 27, 2012
- Review
- 84 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871217 (1987). 2 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 deviceK120341 Plastic Needle with Mandrin 2.0 Diameter Length 113MMVarian Medical Systems, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK141624 Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt…Varian Medical Systems, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK152018 Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop…Varian Medical Systems, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See all- K141624Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt Tip,Plastic Needle with…Varian Medical Systems, Inc. · 2015 · cites it directly1descendant
- K152018Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker SetsVarian Medical Systems, Inc. · 2015 · 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) | 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 | — |
| +2 | K152018 | Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel… | Varian Medical Systems, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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…r Predicate Device Henschke Type GYN Applicator N/A Clearance Number: Set K980590 Compatible Afterloader VanlSource GammaMediplus… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141624 | Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt Tip,Plastic Needle with… | 2015 | 1 |
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 13.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K141624 (Varian Medical Systems, Inc., 2015) has gone furthest, with 1 descendant 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 Interstitial Plastic Needles arte designed for interstitial brachytherapy treatments in areas such as the head and neck, gynecological, breast and prostate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120341: Plastic Needle with Mandrin 2.0 Diameter Length 113MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120341
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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