510(k) · Cleared
ClearedSource Guide Tube with Locking Mechanism for 113 MM Needles, Gammamedplus
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 6, 2014 as substantially equivalent to K113766 (Varian Medical Systems, Inc., 2012) after a 77-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Aug 6, 2014
- Review
- 77 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952913 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK952913 Applicators for Varian Varisource Remote High Soes Rate AfterloaderVarian Assoc., Inc. · 1995
- 1 generation backK113766 Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes…Varian Medical Systems, Inc. · 2012
- This deviceK141336 Source Guide Tube with Locking Mechanism for 113 MM Needles…Varian Medical Systems, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK181903 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide…Varian Medical Systems, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK191580 BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment…Varian Medical Systems, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK221797 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide…Varian Medical Systems, Inc. · 2022
Most influential descendants
Showing 3 of 3 · See all- K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length…Varian Medical Systems, Inc. · 2018 · cites it directly2descendants
- K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceVarian Medical Systems, Inc. · 2019 · 2 generations on1descendant
- K221797BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length…Varian Medical Systems, Inc. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952913 | Applicators for Varian Varisource Remote High Soes Rate Afterloader | Varian Assoc., Inc. | 1995 | — |
| −1 | K113766 | Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes Catheter… | Varian Medical Systems, Inc. | 2012 | — |
| 0 (this device) | K141336 | Source Guide Tube with Locking Mechanism for 113 MM Needles, Gammamedplus | Varian Medical Systems, Inc. | 2014 | — |
| +1 | K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes… | Varian Medical Systems, Inc. | 2018 | — |
| +2 | K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | Varian Medical Systems, Inc. | 2019 | — |
| +3 | K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and… | Varian Medical Systems, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K113766 | Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes Catheter Transfer…Summary page 4…R892.5700 Class II Common/Usual Name: Source Guide Tubes Product code: JAQ Predicate Devices: K113766 VariSource Transfer Guide Tube sets Device Description: Source Guide Tubes are Brachytherapy applicator accessories.… | 2012 |
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 |
|---|---|---|---|
| K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length… | 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 19 years and passes through 2 companies; a new generation was cleared every 16.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181903 (Varian Medical Systems, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K113766.
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. 2014, 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 GammaMedplus Source Guide Tubes are intended to connect between the GammaMedplus Remote Afterloader system and its range of applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient´s tumor site
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141336: Source Guide Tube with Locking Mechanism for 113 MM Needles, Gammamedplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141336
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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