Cleared Traditional

OncoPatch

K252296 · Oncopatch, Inc. · Radiology

Dec 2025

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K252296 is an FDA 510(k) clearance for the OncoPatch, a Source, Brachytherapy, Radionuclide (Class II — Special Controls, product code KXK), submitted by Oncopatch, Inc. (Aurora, US). The FDA issued a Cleared decision on December 5, 2025, 135 days after receiving the submission on July 23, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number	K252296 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2025
Decision Date	December 05, 2025
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF