510(k) · Cleared
ClearedModification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix 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 Jun 18, 2004 as substantially equivalent to K871217 (Mick Radio-Nuclear Instruments, Inc., 1987) and 2 other predicates after a 92-day review. Its family tree reaches back 3 generations to 1991. 3 later devices descend from it.
- Decided
- Jun 18, 2004
- Review
- 92 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K912555 (1991). 5 ancestors in all, the oldest K871217 (1987). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK912555 Gammamed 12IT High Dose Rate Remote AfterloaderRts Technology, Inc. · 1991 · Recalled
- 2 generations backK983436 Gammamed Plus High Dose Rate Remote Afterloading SystemGammamed USA · 1998 · Recalled
- 1 generation backK033371 Varian Intracavitary Brachytherapy ApplicatorsVarian Medical Systems · 2003 · Recalled
- This deviceK040704 Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR…Mick Radio-Nuclear Instruments, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK063381 CT Compatible F/S/D ApplicatorsMick 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 ownK141343 Axxent Cervical ApplicatorIcad, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc. · 2006 · cites it directly1descendant
- K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc. · 2020 · cites it directly0descendants
- K141343Axxent Cervical ApplicatorIcad, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912555 | Gammamed 12IT High Dose Rate Remote Afterloader | Rts Technology, Inc. | 1991 | 2 |
| −2 | K983436 | Gammamed Plus High Dose Rate Remote Afterloading System | Gammamed USA | 1998 | 17 |
| −1 | K033371 | Varian Intracavitary Brachytherapy Applicators | Varian Medical Systems | 2003 | 2 |
| 0 (this device) | K040704 | Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix… | Mick Radio-Nuclear Instruments, Inc. | 2004 | — |
| +1 | K063381 | CT Compatible F/S/D Applicators | 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 | K141343 | Axxent Cervical Applicator | Icad, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K871217 | Henschke Afterloading ApplicatorSummary page 1…Predicate Devices: (I) Model and Manufacturer K Number Henschke Applicator; Mick Radio-Nuclear K871217 Instruments, Inc. Hilaris/Nori Applicator; Mick Radio-Nuclear K89 1377 Instruments, Inc.… | 1987 |
| * | K891377 | Hilaris-Nori Cervix ApplicatorSummary page 1…K Number Henschke Applicator; Mick Radio-Nuclear K871217 Instruments, Inc. Hilaris/Nori Applicator; Mick Radio-Nuclear K89 1377 Instruments, Inc. Cervix Applicator; Varian Medical Systems, Inc. K033371 Any s… | 1989 |
| * | K033371 | Varian Intracavitary Brachytherapy ApplicatorsSummary page 1…ts, Inc. Hilaris/Nori Applicator; Mick Radio-Nuclear K89 1377 Instruments, Inc. Cervix Applicator; Varian Medical Systems, Inc. K033371 Any statement made in conjunction with this submission regarding substantial equivalence… | 2003 |
| † | K001544 | Vaginal Applicator Shielded | 2000 |
| † | K011657 | HDR Tandem/Ring Applicator with Rectal Retractor | 2001 |
What descends from it? (3)
3 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 13 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K063381 (Mick Radio-Nuclear Instruments, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K871217.
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 applicators presented in this 510(k) notification have been developed to function as Applicators for the positioning of HDR Remote After-Loader sealed sources in the intracavitary treatment of cancer of the vagina and cervix.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040704: Modification to Henschke HDR Cervix Applicator and Hilaris/Nori HDR Cervix Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040704
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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