510(k) · Cleared
ClearedKobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube 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 Apr 3, 2014 as substantially equivalent to K113766 (Varian Medical Systems, Inc., 2012) and 1 other predicate after a 379-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Apr 3, 2014
- Review
- 379 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K811279 (1981). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK811279 Afterloading Catheter SetMick Radio-Nuclear Instruments, Inc. · 1981
- 1 generation backK051423 Mick HDR Interstitial Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2005
- This deviceK130757 Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer…Spencer Fillmore · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K811279 | Afterloading Catheter Set | Mick Radio-Nuclear Instruments, Inc. | 1981 | — |
| −1 | K051423 | Mick HDR Interstitial Implant Accessories | Mick Radio-Nuclear Instruments, Inc. | 2005 | — |
| 0 (this device) | K130757 | Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube Set | Spencer Fillmore | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K113766 | Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes Catheter Transfer…Summary page 4…___________ K-Number 130757 113766 Device Description Transfer Tube Set Transfer Tube Set Indications For Use T… | 2012 |
| * | K051423 | Mick HDR Interstitial Implant AccessoriesSummary page 6…MICK RADIO-NUCLEAR®. INC. EQUIVALENCE TABLE __________________________ K-Number 130757 051423 Device Description Needle Extender Set Needle Extender Set Indications F IrUse The interstitia… | 2005 |
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 33 years and passes through 2 companies; a new generation was cleared every 23.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K113766.
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. 2014, 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 Secure Lock transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site. Transfer guide tubes are non-invasive products that have no direct patient contact. The Luer transfer guide tubes have been developed to…
Read the full statement (185 words)
The Secure Lock transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.
Transfer guide tubes are non-invasive products that have no direct patient contact.
The Luer transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators that include a Luer style connection. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.
Transfer guide tubes are non-invasive products that have no direct patient contact.
The Luer interstitial extenders have been developed to enable the connection of Luer transfer guide tube to Kobold Interstitial Needles. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.
Interstitial extenders are non-invasive products that have no direct patient contact.
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/K130757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130757: Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130757
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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