Cleared Traditional

K141958 - ERB ENDORECTAL BALLOON (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141958 · Edge Medical, LLC · Radiology device
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Nov 2014
Decision
123d
Days
Class 2
Risk

K141958 is an FDA 510(k) clearance for the ERB ENDORECTAL BALLOON. Classified as Prostate Immobilizer Rectal Balloon (product code PCT), Class II - Special Controls.

Submitted by Edge Medical, LLC (Lutsen, US). The FDA issued a Cleared decision on November 18, 2014 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5720 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K141958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2014
Decision Date November 18, 2014
Days to Decision 123 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 107d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.