510(k) · Cleared
ClearedVaginal Applicator Shielded
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 Nov 17, 2000 after a 183-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 17, 2000
- Review
- 183 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK001544 Vaginal Applicator ShieldedMick Radio-Nuclear Instruments, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK092534 Alatus Vaginal Balloon Packing SystemRadiadyne · 2009
- Descendant · cites it directly · 1 of its ownK052351 HDR Iort Shielded ApplicatorMick Radio-Nuclear Instruments, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK120344 Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer) · 2012
- Descendant · 2 generations on · 0 of its ownK062135 Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC · 2006
Most influential descendants
Showing 4 of 4 · See all- K092534Alatus Vaginal Balloon Packing SystemRadiadyne · 2009 · cites it directly1descendant
- K052351HDR Iort Shielded ApplicatorMick Radio-Nuclear Instruments, Inc. · 2005 · cites it directly1descendant
- K120344Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer) · 2012 · 2 generations on0descendants
- K062135Art Shielded Breast ApplicatorAdvanced Radiation Therapy, LLC · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001544 | Vaginal Applicator Shielded | Mick Radio-Nuclear Instruments, Inc. | 2000 | — |
| +1 | K092534 | Alatus Vaginal Balloon Packing System | Radiadyne | 2009 | — |
| +1 | K052351 | HDR Iort Shielded Applicator | Mick Radio-Nuclear Instruments, Inc. | 2005 | — |
| +2 | K120344 | Radiapak Brachytherapy Applicator Balloon Device | Radiadyne, LLC (Specification Developer) | 2012 | — |
| +2 | K062135 | Art Shielded Breast Applicator | Advanced Radiation Therapy, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K092534 (Radiadyne, 2009) has gone furthest, with 1 descendant of its own.
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 | — |
https://510kreport.com/device/K001544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001544: Vaginal Applicator Shielded.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001544
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026