510(k) · Cleared
ClearedKobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spencer Fillmore · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on May 14, 2013 as substantially equivalent to K011657 (Mick Radio-Nuclear Instruments, Inc., 2001) after a 146-day review. Its family tree reaches back 3 generations to 1986. 2 later devices descend from it.
- Decided
- May 14, 2013
- Review
- 146 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K864210 (1986). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 2 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 1 generation backK011657 HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2001 · Recalled
- This deviceK123912 Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator…Spencer Fillmore · 2013
- Descendant · cites it directly · 0 of its ownK160610 Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold…Kobold, LLC · 2017
- Descendant · cites it directly · 0 of its ownK142330 Kobold Ring and Tandem Applicator SetKobold, LLC · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −2 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −1 | K011657 | HDR Tandem/Ring Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | 2001 | 2 |
| 0 (this device) | K123912 | Kobold Fletcher Type Applicator Set, Kobold Henschke Type Applicator Set | Spencer Fillmore | 2013 | — |
| +1 | K160610 | Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model… | Kobold, LLC | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K011657 | HDR Tandem/Ring Applicator with Rectal Retractor | 2001 |
What descends from it? (2)
2 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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160610 (Kobold, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K011657.
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. 2013, 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/MRI Compatible HDR Fletcher Type Applicator is indicated for use in any, case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by tip-to-date clinical guidelines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123912: Kobold Fletcher Type Applicator Set, Kobold Henschke Type 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/K123912
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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