510(k) · Cleared
ClearedHDR CT Compatible Split Ring Applicator
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 Dec 26, 2006 as substantially equivalent to K030110 (Mick Radio-Nuclear Instruments, Inc., 2003) and 2 other predicates after a 48-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it.
- Decided
- Dec 26, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K864210 (1986). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 backK030110 CT HDR Tandem/Ring Applicator with Rectal RetractorMick Radio-Nuclear Instruments, Inc. · 2003 · Recalled
- This deviceK063382 HDR CT Compatible Split Ring ApplicatorMick Radio-Nuclear Instruments, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK200221 CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem…Mick Radio-Nuclear Instruments, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK082530 Applicators for Afterloading BrachytherapyIsodose Control B.V. · 2008
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 |
|---|---|---|---|---|---|
| −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 | K030110 | CT HDR Tandem/Ring Applicator with Rectal Retractor | Mick Radio-Nuclear Instruments, Inc. | 2003 | 1 |
| 0 (this device) | K063382 | HDR CT Compatible Split Ring Applicator | Mick Radio-Nuclear Instruments, Inc. | 2006 | — |
| +1 | K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid… | Mick Radio-Nuclear Instruments, Inc. | 2020 | — |
| +1 | K082530 | Applicators for Afterloading Brachytherapy | Isodose Control B.V. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2020 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030110 | CT HDR Tandem/Ring Applicator with Rectal RetractorSummary page 2…Device Manufacturer K Number CT HDR Tandem / Ring Mick Radio-Nuclear Instruments, K030110 Applicator with Rectal Retractor Inc. HDR Tandem/Ring Applicator Mick Radio-Nuclear Instruments,… | 2003 |
| * | K011657 | HDR Tandem/Ring Applicator with Rectal RetractorSummary page 2…Radio-Nuclear Instruments, K030110 Applicator with Rectal Retractor Inc. HDR Tandem/Ring Applicator Mick Radio-Nuclear Instruments, K011657 with Rectal Retractor Inc H.A.M. Applicator Mick Radio-Nuclear Instruments,… | 2001 |
| * | K961601 | H.a.M. ApplicatorSummary page 2…Radio-Nuclear Instruments, K011657 with Rectal Retractor Inc H.A.M. Applicator Mick Radio-Nuclear Instruments, K961601 Inc Any statement made in conjunction with this submission… | 1996 |
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 20 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K200221 (Mick Radio-Nuclear Instruments, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K030110.
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 HDR CT Compatible Split Ring type applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.
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/K063382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063382: HDR CT Compatible Split Ring Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063382
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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