510(k) · Cleared
ClearedPro-Tx Endorectal Balloon (PROT-25)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dxtx Medical, Inc. · PCT Prostate Immobilizer Rectal Balloon
Cleared on Feb 10, 2023 as substantially equivalent to DEN130036 (Radiadyne, 2014) after a 151-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Feb 10, 2023
- Review
- 151 days
- Class
- Class II
- Product code
- PCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130036 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backDEN130036 Prostate Immobilizer Rectal BalloonRadiadyne · 2014
- This deviceK223249 Pro-Tx Endorectal Balloon (PROT-25)Dxtx Medical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130036 | Prostate Immobilizer Rectal Balloon | Radiadyne | 2014 | — |
| 0 (this device) | K223249 | Pro-Tx Endorectal Balloon (PROT-25) | Dxtx Medical, Inc. | 2023 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | DEN130036 | Prostate Immobilizer Rectal Balloon Our reading of the summary gave K132194, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130036, Prostate Immobilizer Rectal Balloon (Radiadyne), granted Jan 28, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2014 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate DEN130036.
How does its category compare?
All PCT devicesPCT Prostate Immobilizer Rectal Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 DxTx Medical Pro-Tx Endorectal Balloon is a disposable, single use non-powered inflatable positioning device intended to be used for temporary positioning of the rectal wall and adjacent structures in the male human anatomies and to assist in positioning the prostate in a more predictable and reproducible location.
The purpose of the DxTx Medical Pro-Tx Endorectal Balloon is to stabilize the rectal wall and surrounding anatomy during all phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery. Only trained healthcare professionals are intended to operate this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223249: Pro-Tx Endorectal Balloon (PROT-25).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223249
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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