510(k) · Cleared
ClearedRadiapak Brachytherapy Applicator Balloon Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiadyne, LLC (Specification Developer) · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on May 3, 2012 as substantially equivalent to K092822 (Vivaray, Inc., 2009) and 1 other predicate after a 90-day review. Its family tree reaches back 6 generations to 1986.
- Decided
- May 3, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K864210 (1986). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 5 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 4 generations backK020015 Implant Guidance System Applicator SetNucletron Corp. · 2002
- 3 generations backK032372 Nucletron Comfort Catheter System, Model 189.007Nucletron Corporation · 2003
- 2 generations backK061241 Biolucent Applicator, Model Rta-XXBiolucent, Inc. · 2006
- 1 generation backK092822 Capri ApplicatorVivaray, Inc. · 2009
- This deviceK120344 Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer) · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −5 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −4 | K020015 | Implant Guidance System Applicator Set | Nucletron Corp. | 2002 | — |
| −3 | K032372 | Nucletron Comfort Catheter System, Model 189.007 | Nucletron Corporation | 2003 | — |
| −2 | K061241 | Biolucent Applicator, Model Rta-XX | Biolucent, Inc. | 2006 | — |
| −1 | K092822 | Capri Applicator | Vivaray, Inc. | 2009 | — |
| 0 (this device) | K120344 | Radiapak Brachytherapy Applicator Balloon Device | Radiadyne, LLC (Specification Developer) | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K092822 | Capri ApplicatorSummary page 2…on Panel: Radiology Regulatory Class: Class 2 Predicate Devices 1. CapriT" Applicator (K092822) 2. Alatus® Vaginal Balloon Packing System (K(092534) indications for Use The RadiaPak' Brachytherapy Applicator Balloo… | 2009 |
| * | K092534 | Alatus Vaginal Balloon Packing SystemSummary page 4…Tm Device, as designed and manufactured, is therefore determined to be substantially equivalent to the Capri TM and Alatus® devices previously cleared under K092822 and K092534, respectively. Page I4 4 DEPARTMENT OF HEALTH & HUMAN SERVICES Public… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K092822.
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. 2012, 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 RadiaPak Tm Brachytherapy Applicator Balloon Device is a single use, non-sterile, disposable, inflatable, non-powered positioning device, manufactured without the use of latex, intended to be used on a daily treatment basis to position and stabilize the brachytherapy radiation delivery applicator within the vagina or rectum during brachytherapy radiation therapy procedures, x-ray, or computed tomography (CT) exam. The placement of the balloon device requires a physician or physician directed healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120344: Radiapak Brachytherapy Applicator Balloon Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120344
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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