510(k) · Cleared
ClearedKobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kobold, LLC · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Feb 13, 2017 as substantially equivalent to K123912 (Spencer Fillmore, 2013) and 1 other predicate after a 347-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Feb 13, 2017
- Review
- 347 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K912555 (1991). 9 ancestors in all, the oldest K864210 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK912555 Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 1991 · Recalled
- 3 generations backK983436 Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 1998 · Recalled
- 2 generations backK033371 Varian Intracavitary Brachytherapy ApplicatorsVarian Medical Systems · 2003 · Recalled
- 1 generation backK123941 Kobold Sure-Guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set…Spencer Fillmore · 2013
- This deviceK160610 Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold…Kobold, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912555 | Gammamed 12IT High Dose Rate Remote Afterloader | Rts Technology, Inc. | 1991 | 2 |
| −3 | K983436 | Gammamed Plus High Dose Rate Remote Afterloading System | Gammamed USA | 1998 | 17 |
| −2 | K033371 | Varian Intracavitary Brachytherapy Applicators | Varian Medical Systems | 2003 | 2 |
| −1 | K123941 | Kobold Sure-Guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set, Miami… | Spencer Fillmore | 2013 | — |
| 0 (this device) | K160610 | Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model… | Kobold, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K123912 | Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator SetSummary page 7…sign, has the same fundamental technology and uses the same general sterilization procedures. Please see predicate device brochures in Appendix C and previously cleared K123912 and K123941. A. Predicate device name: Kobold® Fletcher Type Applicator Set, Kobold® Henschke Type Applicator Set, Ko… | 2013 |
| * | K123941 | Kobold Sure-Guide Vaginal Cylinder Set, Stump Vaginal Cylinder Set, Miami Cylinder SetSummary page 7…e same fundamental technology and uses the same general sterilization procedures. Please see predicate device brochures in Appendix C and previously cleared K123912 and K123941. A. Predicate device name: Kobold® Fletcher Type Applicator Set, Kobold® Henschke Type Applicator Set, Kobold® Vagina… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 5 companies; a new generation was cleared every 7.2 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 1 other device also cites its predicate K123912.
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. 2017, 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 CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Fletcher type applicator is accepted by up-to-date clinical guidelines. The Kobold® Fletcher-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient. The CT Compatible / MR Unsafe HDR Kobold®…
Read the full statement (251 words)
The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Fletcher type applicator is accepted by up-to-date clinical guidelines. The Kobold® Fletcher-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Henschke type applicator is accepted by up-to-date clinical guidelines. The Kobold® Henschke-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the vagina is accepted by up-to-date clinical guidelines. The Kobold® Vaginal Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set is indicated for use in any patient case where high dose rate (HDR) radiation treatment of the cervix, vagina, and uterus with a Miami type applicator is acceptable by up-to-date clinical guidelines. The Kobold® Miami Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160610 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160610: Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160610
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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