Cleared Abbreviated

K223249 - Pro-Tx Endorectal Balloon (PROT-25) (FDA 510(k) Clearance)

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K223249 · Dxtx Medical, Inc. · Radiology device
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Feb 2023
Decision
151d
Days
Class 2
Risk

K223249 is an FDA 510(k) clearance for the Pro-Tx Endorectal Balloon (PROT-25). Classified as Prostate Immobilizer Rectal Balloon (product code PCT), Class II - Special Controls.

Submitted by Dxtx Medical, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 10, 2023 after a review of 151 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5720 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dxtx Medical, Inc. devices

Submission Details

510(k) Number K223249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2022
Decision Date February 10, 2023
Days to Decision 151 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 107d · This submission: 151d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code PCT Prostate Immobilizer Rectal Balloon
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5720
Definition Intended To Be Used For The Temporary Positioning Of The Rectal Wall And Adjacent Structure In The Male Human Anatomies. The Purpose Is To Stabilize The Prostate During Computed Tomography (ct) Exam, X-ray, Or Radiation Therapy (rt) Treatments. 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.