510(k) · Cleared

Cleared

Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301

K150234510(k) TraditionalCleared Mar 31, 201557-day reviewClass II21 CFR 892.5720

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Myriad Medical, LLC · PCT Prostate Immobilizer Rectal Balloon

Cleared on Mar 31, 2015 as substantially equivalent to DEN130036 (Radiadyne, 2014) after a 57-day review. Its family tree reaches back 1 generation to 2014. 1 later device descends from it.

Decided: Mar 31, 2015
Review: 57 days
Class: Class II
Product code: PCT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN130036 (2014). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN130036 Prostate Immobilizer Rectal BalloonRadiadyne · 2014
This deviceK150234 Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301Myriad Medical, LLC · 2015
Descendant · cites it directly · 0 of its ownK180478 RectalPro 75 Endorectal BalloonQlrad International, Ltd. · 2018

Most influential descendants

Showing 1 of 1 · See all

K180478RectalPro 75 Endorectal BalloonQlrad International, Ltd. · 2018 · cites it directly0descendants

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)	K150234	Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301	Myriad Medical, LLC	2015	—
+1	K180478	RectalPro 75 Endorectal Balloon	Qlrad International, Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K150234, 2014–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	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.	Radiadyne	2014	—

Also cleared against DEN130036: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K180478	RectalPro 75 Endorectal Balloon	Qlrad International, Ltd.	2018	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?

Its one ancestor has no recall.
Of its descendants, K180478 (Qlrad International, Ltd., 2018) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate DEN130036.

How does its category compare?

All PCT devices

PCT Prostate Immobilizer Rectal Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · PCT

1in 2023

2007high 2 (2014) · low 0 (2007)2026

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

2007high 1 (2023) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	2	—	0
2015	1	—	0
2016	0	—	0
2017	0	—	0
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Myriad Prostate Caddy™ Immobilization Rectal Balloon is a single-use disposable, inflatable, non-powered positioning device intended for use 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. The placement of the balloon requires a Physician or a Physician directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K150234 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150234: Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150234

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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