510(k) · Cleared
ClearedVarisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate Afterioader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Assoc., Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Oct 21, 1998 as substantially equivalent to K890485 (Mick Radio-Nuclear Instruments, Inc., 1989) after a 246-day review. Its family tree reaches back 1 generation to 1989. 18 later devices descend from it.
- Decided
- Oct 21, 1998
- Review
- 246 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890485 (1989). 18 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK890485 Wang Front Loading ApplicatorMick Radio-Nuclear Instruments, Inc. · 1989
- This deviceK980601 Varisource Wright Vaginal Cuff Applicator for Varian Varisource…Varian Assoc., Inc. · 1998
- Descendant · cites it directly · 17 of its ownK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
- 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
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K061241Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006 · cites it directly17descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890485 | Wang Front Loading Applicator | Mick Radio-Nuclear Instruments, Inc. | 1989 | — |
| 0 (this device) | K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High… | Varian Assoc., Inc. | 1998 | — |
| +1 | K061241 | Biolucent Applicator, Model Rta-XX | Biolucent, Inc. | 2006 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K890485 | Wang Front Loading ApplicatorSummary page 1…VariSource Wright Vaginal Cuff Applicator for Varian VariSource™ Remote High Dose Rate Afterloader. Mick Radio-Nuclear Instruments, Inc., Wang Front Loading Applicator, K890485. Applicators for the Varian VariSource Remote High Dose Rate Afterloader are a part of a remote controlled radionuclide applicat… | 1989 |
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K061241 (Biolucent, Inc., 2006) has gone furthest, with 17 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.
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 Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Wright Vaginal Cuff applicator which is the subject of this 510(k) is a component of the VariSource system.
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/K980601 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980601: Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate Afterioader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980601
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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