510(k) · Cleared
Recalled · 2011Varian Intracavitary Brachytherapy Applicators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Dec 24, 2003 as substantially equivalent to K983436 (Gammamed USA, 1998) after a 64-day review. Its family tree reaches back 2 generations to 1991. 29 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 24, 2003
- Review
- 64 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912555 (1991). 29 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK912555 Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 1991 · Recalled
- 1 generation backK983436 Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 1998 · Recalled
- This deviceK033371 Varian Intracavitary Brachytherapy ApplicatorsVarian Medical Systems · 2003
- Descendant · cites it directly · 13 of its ownK070659 Biolucent Applicator KitBiolucent, Inc. · 2007
- Descendant · 2 generations on · 12 of its ownK080565 Modification to: Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · cites it directly · 11 of its ownK081677 Savi Applicator KitCianna Medical, Inc. · 2008
- Descendant · 2 generations on · 9 of its ownK091378 Mammosite II Radiation Therapy SystemHologic, Inc. · 2009
- Descendant · 3 generations on · 8 of its ownK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K070659Biolucent Applicator KitBiolucent, Inc. · 2007 · cites it directly13descendants
- K080565Modification to: Savi Applicator KitCianna Medical, Inc. · 2008 · 2 generations on12descendants
- K081677Savi Applicator KitCianna Medical, Inc. · 2008 · cites it directly11descendants
- K091378Mammosite II Radiation Therapy SystemHologic, Inc. · 2009 · 2 generations on9descendants
- K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912555 | Gammamed 12IT High Dose Rate Remote Afterloader | Rts Technology, Inc. | 1991 | 2 |
| −1 | K983436 | Gammamed Plus High Dose Rate Remote Afterloading System | Gammamed USA | 1998 | 17 |
| 0 (this device) | K033371 | Varian Intracavitary Brachytherapy Applicators | Varian Medical Systems | 2003 | — |
| +1 | K070659 | Biolucent Applicator Kit | Biolucent, Inc. | 2007 | — |
| +2 | K080565 | Modification to: Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +1 | K081677 | Savi Applicator Kit | Cianna Medical, Inc. | 2008 | — |
| +2 | K091378 | Mammosite II Radiation Therapy System | Hologic, Inc. | 2009 | — |
| +3 | K121653 | Intrabeam System with Intrabeam Spherical Applicators | Carl Zeiss Meditec, Inc. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K983436 | Gammamed Plus High Dose Rate Remote Afterloading SystemSummary page 1…Brachytherapy Applicators 3) Predicate Device Name: GammaMed Plus High Dose Rate Afterloader System applicators, K 983436 4) Description: The applicator sets in this submission are designed to be used with the… | 1998 |
What descends from it? (29)
See all 298 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070659 | Biolucent Applicator Kit | 2007 | 13 |
| K081677 | Savi Applicator Kit | 2008 | 11 |
| K141490 | Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set | 2014 | 4 |
| K040704 | Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix Applicator | 2004 | 3 |
| K151657 | Shielded Applicator Set, Cervical Stop | 2015 | 1 |
| K123941 | Kobold Sure-Guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set, Miami Cylinder Set | 2013 | 1 |
| K072616 | Axxent Vaginal Applicator | 2008 | 0 |
| K062135 | Art Shielded Breast Applicator | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2011 | Not classified | Z-3055-2011 | Device Design | Blocking washers on the Flexible Probe with Blocking washers may shift and cause potential for treatment length error. |
| May 20, 2010 | Not classified | Z-0282-2012 | Labeling Change Control | The Instructions For Use ( IFU) distributed with product prior to 2004 lacks the correct limit to the sterilization cycles and checks regarding the firm seating of the blocking washer. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K070659 (Biolucent, Inc., 2007) has gone furthest, with 13 descendants of its own.
- 12 other devices also cite its predicate K983436.
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.
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 applicators will be used with the VanSource High Dose Rate Afterloaders to deliver
brachytherapy treatment for gynecological and rectal applications. The applicators will be
used in medical intracavitary for treatment of cancerous tumors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033371 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033371: Varian Intracavitary Brachytherapy Applicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033371
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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