510(k) · Cleared
ClearedMick HDR Interstitial Implant Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mick Radio-Nuclear Instruments, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Jul 1, 2005 as substantially equivalent to K890341 (Mick Radio-Nuclear Instruments, Inc., 1989) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it.
- Decided
- Jul 1, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K811279 (1981). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK811279 Afterloading Catheter SetMick Radio-Nuclear Instruments, Inc. · 1981
- This deviceK051423 Mick HDR Interstitial Implant AccessoriesMick Radio-Nuclear Instruments, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK130757 Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer…Spencer Fillmore · 2014
Most influential descendants
Showing 1 of 1 · See all- K130757Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube SetSpencer Fillmore · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811279 | Afterloading Catheter Set | Mick Radio-Nuclear Instruments, Inc. | 1981 | — |
| 0 (this device) | K051423 | Mick HDR Interstitial Implant Accessories | Mick Radio-Nuclear Instruments, Inc. | 2005 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K890341 | Mick 200-TP and Mick TP NeedleSummary page 1…: (I) Device Manu facturer K Number Mick TP Needle Mick Radio-Nuclear Instruments, K890341 Inc. Afterloading Catheter Set Mick Radio-Nuclear Instruments, K811279… | 1989 |
| * | K811279 | Afterloading Catheter SetSummary page 1…Mick Radio-Nuclear Instruments, K890341 Inc. Afterloading Catheter Set Mick Radio-Nuclear Instruments, K811279 Inc Interstitial Implant Set Best Medical Industries K933400… | 1981 |
| Kept off the family tree | K933400 | FDA’s K933400 is Kendall Curity 100% Silicone Foley Catheter W/Temperature Sensor Our reading of the summary gave K933400, FDA’s number for Kendall Curity 100% Silicone Foley Catheter W/Temperature… (Kendall Healthcare Products Co. Div.Of Tyco Health). Its FDA name has none of the distinctive words the summary uses for the device it names, “Interstitial Implant Set”. Kept off the family tree. Summary page 1…t Mick Radio-Nuclear Instruments, K811279 Inc Interstitial Implant Set Best Medical Industries K933400 Any statement made in conjunction with this submission regarding… | 1993 |
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 |
|---|---|---|---|
| K130757 | Kobold Secure Lock Transfer Guide Tube Set; Kobold Luer Transfer Guide Tube Set | 2014 | 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?
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.
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 Mick IHDR Interstitial Implant Accessories (consisting of needles, catheters, and fixation buttons) presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader sealed sources in the interstitial treatment of cancer of the oral cavity, oropharyngeal tumors, head and neck and soft tissue sarcomas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051423: Mick HDR Interstitial Implant Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051423
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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