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510(k) Summary 82012 8 21 CFR 807 - accessdata fda

510(k) Summary 82012 8 21 CFR 807 - accessdata fda 2025

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The document is a 510(k) summary for the PERFORMER HT system, a prescription electromechanical device designed for isolated hyperthermic perfusion in the thoracic or peritoneal cavity using warmed sterile solutions. It details the device's classification, intended use, technological characteristics, non-clinical testing results, and compliance with FDA standards. The summary concludes that the PERFORMER HT is substantially equivalent to the Belmont Hyperthermia Pump and does not raise new safety or effectiveness questions.

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What are the requirements for 510k clearance?

The FDA 510k submission requirements include extensive technical documentation such as proposed labeling, sterilization and shelf life data, biocompatibility research, animal, clinical and bench performance testing and other technical evidence needed to establish substantial equivalence and receive FDA 510k clearance.

How long does FDA 510k clearance take?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

What is 21 CFR Part 807 FDA?

Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).

What is FDA 510k approved?

The FDAs 510(k) submission process is, in a nutshell, a clearance process which every company wanting to bring a medium-risk medical device to the American market must pass through. Almost half of all medical devices used in the United States every day will have passed through the 510(k) route.

What is the difference between FDA and FDA 510k?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FDC Act).

What does FDA granted 510 K clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

510(k) Summary 82012 8 21 CFR 807 - accessdata fda 2025

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