De Novo · Granted
GrantedProstate Immobilizer Rectal Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiadyne · PCT Prostate Immobilizer Rectal Balloon
Granted on Jan 28, 2014 as a new device type through De Novo after a 197-day review. 8 later devices descend from it.
- Decided
- Jan 28, 2014
- Review
- 197 days
- Class
- Class II
- Product code
- PCT
- Recalls
- None
8 later devices descend from it, 4 citing it directly.
- This deviceDEN130036 Prostate Immobilizer Rectal BalloonRadiadyne · 2014
- Descendant · cites it directly · 3 of its ownK141154 Oartrac SystemRadiadyne · 2014
- Descendant · 2 generations on · 2 of its ownK150719 OARtrac System with Skin SensorsRadiadyne, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK162954 OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC · 2017
- Descendant · cites it directly · 1 of its ownK150234 Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301Myriad Medical, LLC · 2015
- Descendant · cites it directly · 0 of its ownK223249 Pro-Tx Endorectal Balloon (PROT-25)Dxtx Medical, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K141154Oartrac SystemRadiadyne · 2014 · cites it directly3descendants
- K150719OARtrac System with Skin SensorsRadiadyne, LLC · 2015 · 2 generations on2descendants
- K162954OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC · 2017 · 2 generations on1descendant
- K150234Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301Myriad Medical, LLC · 2015 · cites it directly1descendant
- K223249Pro-Tx Endorectal Balloon (PROT-25)Dxtx Medical, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN130036 | Prostate Immobilizer Rectal Balloon | Radiadyne | 2014 | — |
| +1 | K141154 | Oartrac System | Radiadyne | 2014 | — |
| +2 | K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | 2015 | — |
| +2 | K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | Radiadyne, LLC | 2017 | — |
| +1 | K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 | Myriad Medical, LLC | 2015 | — |
| +1 | K223249 | Pro-Tx Endorectal Balloon (PROT-25) | Dxtx Medical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA De Novo 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 PCT? 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 PCT device
- #1 K223249 Pro-Tx Endorectal Balloon (PROT-25)score 4.8 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
4 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, K141154 (Radiadyne, 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All PCT devicesPCT Prostate Immobilizer Rectal Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PCT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PCT
Too few PCT 510(k)s in any year since 2007 to give a median.
Recalls per year · PCT
No recall names PCT since 2007.
Adverse event reports per year · PCT
1in 2023
MAUDE reports naming product code PCT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN130036 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN130036: Prostate Immobilizer Rectal Balloon.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130036
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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