510(k) · Cleared
ClearedAlatus Vaginal Balloon Packing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiadyne · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Dec 7, 2009 as substantially equivalent to K001544 (Mick Radio-Nuclear Instruments, Inc., 2000) and 1 other predicate after a 110-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Dec 7, 2009
- Review
- 110 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001544 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK001544 Vaginal Applicator ShieldedMick Radio-Nuclear Instruments, Inc. · 2000
- This deviceK092534 Alatus Vaginal Balloon Packing SystemRadiadyne · 2009
- Descendant · cites it directly · 0 of its ownK120344 Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer) · 2012
Most influential descendants
Showing 1 of 1 · See all- K120344Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer) · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001544 | Vaginal Applicator Shielded | Mick Radio-Nuclear Instruments, Inc. | 2000 | — |
| 0 (this device) | K092534 | Alatus Vaginal Balloon Packing System | Radiadyne | 2009 | — |
| +1 | K120344 | Radiapak Brachytherapy Applicator Balloon Device | Radiadyne, LLC (Specification Developer) | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K001544 | Vaginal Applicator Shielded | 2000 |
| * | K002912 | Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073Summary page 3…terine cavity. Predicate Devicefs) 1. Mick Radio-Nuclear Instruments, Inc. - Vaginal Applicator Shielded (KO0l1544) 2. Sterilis, Inc. - Vaginal Port Inflatable Speculum (K002912) Safety and Effectiveness By definition, a device is substantially equivalent to a predicate device when the device has the same… | 2001 |
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 |
|---|---|---|---|
| K120344 | Radiapak Brachytherapy Applicator Balloon Device | 2012 | 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. 2009, 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 ALATUS Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092534: Alatus Vaginal Balloon Packing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092534
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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