510(k) · Cleared
ClearedRectalPro 75 Endorectal Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qlrad International, Ltd. · PCT Prostate Immobilizer Rectal Balloon
Cleared on Nov 13, 2018 as substantially equivalent to K150234 (Myriad Medical, LLC, 2015) after a 264-day review. Its family tree reaches back 2 generations to 2014.
- Decided
- Nov 13, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- PCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN130036 (2014). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 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
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K150234 | Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301Summary page 5…== Page 5 === Page 2 of 6 5. Legally Marketed Predicate Device(s) K150234, Myriad Prostate Caddy™ Immobilization Rectal Balloon Item, Myriad Medical, LLC 6. Indication for Use Statement The RectalPro… | 2015 |
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 4 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All PCT devicesPCT Prostate Immobilizer Rectal Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 | — |
What is it indicated for?
The RectalPro™75 Endorectal Balloon device is a single-use disposable, inflatable, non-powered positioning device
intended for us in the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The
purpose of the device is to stabilize the prostate during Computed Tomography (CT) exam, and X-Ray when these
imaging techniques are used for Radiation Therapy (RT) planning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180478 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180478: RectalPro 75 Endorectal Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180478
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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