510(k) · Cleared
ClearedVarian Esophagus Bougie Applicator
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 Mar 1, 2007 as substantially equivalent to K891131 (Mick Radio-Nuclear Instruments, Inc., 1989) and 1 other predicate after a 69-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Mar 1, 2007
- Review
- 69 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K912555 (1991). 3 ancestors in all, the oldest K891131 (1989). 1 later device descends from it, 1 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 deviceK063815 Varian Esophagus Bougie ApplicatorVarian Medical Systems · 2007
- Descendant · cites it directly · 0 of its ownK082530 Applicators for Afterloading BrachytherapyIsodose Control B.V. · 2008
Most influential descendants
Showing 1 of 1 · See all- K082530Applicators for Afterloading BrachytherapyIsodose Control B.V. · 2008 · cites it directly0descendants
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) | K063815 | Varian Esophagus Bougie Applicator | Varian Medical Systems | 2007 | — |
| +1 | K082530 | Applicators for Afterloading Brachytherapy | Isodose Control B.V. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K891131 | Gammamed 12ISummary page 1…Class 11 Product Code: JAQ * Predicate Devices to claim substantial equivalence: K891131 & K983436 * Description of the Device: The Varian Esophagus Bougie is an HOR applicator designed to facilitate del… | 1989 |
| * | K983436 | Gammamed Plus High Dose Rate Remote Afterloading SystemSummary page 1…Class 11 Product Code: JAQ * Predicate Devices to claim substantial equivalence: K891131 & K983436 * Description of the Device: The Varian Esophagus Bougie is an HOR applicator designed to facilitate delivery of r… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082530 | Applicators for Afterloading Brachytherapy | 2008 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K082530 (Isodose Control B.V., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K891131.
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. 2007, 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 Varian Esophagus Bougie is an applicator used to facilitate delivery of a prescription of radiation to the esophagus when used in conjunction with a Varian high dose rate afterloader.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063815: Varian Esophagus Bougie Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063815
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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