510(k) · Cleared
ClearedKobold Ring and Tandem 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 Apr 9, 2015 as substantially equivalent to K123912 (Spencer Fillmore, 2013) after a 232-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Apr 9, 2015
- Review
- 232 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K864210 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 3 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 2 generations backK011657 HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2001 · Recalled
- 1 generation backK123912 Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator…Spencer Fillmore · 2013
- This deviceK142330 Kobold Ring and Tandem Applicator SetKobold, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −3 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −2 | K011657 | HDR Tandem/Ring Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | 2001 | 2 |
| −1 | K123912 | Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator Set | Spencer Fillmore | 2013 | — |
| 0 (this device) | K142330 | Kobold Ring and Tandem Applicator Set | Kobold, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 |
|---|---|---|---|
| * | K123912 | Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator SetSummary page 6…s or performance standards for this device. 7. Bench Testing Extensive testing in accordance with known standards is documented by the manufacturer for predicate device K123912. The standard is a specification for the materials used in surgical implant applications and predicate brachytherapy devices and… | 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 29 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 5 ancestors has 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. 2015, 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 Ring and Tandem Applicator Set is indicated for use in any case where
high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines.
The Kobold Ring and Tandem Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
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/K142330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142330: Kobold Ring and Tandem Applicator Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142330
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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