What Is This Device?
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.
How Is PCT Classified?
Prostate Immobilizer Rectal Balloon is FDA product code PCT, Class 2, 21 CFR 892.5720.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.
A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Has Gone Wrong With It?
The FDA has recorded 2 recalls under this product code since 2024. None was by a company in China. The root cause the FDA records most often is Process control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.