Choosing the Right Predicate Device for Your 510(k) Submission. If you aim FDA 510 K Submission, the … A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. By searching the online FDA 510(k) Database, medical device manufacturers quickly sort through current medical devices that are either available for sale or approved for sale in the U.S. Once an approved medical device is identified, the similarities between the current and proposed devices are established. The U.S. Food and Drug Administration established the FDA database for 510(k) clearances to serve as a repository for classification information about medical devices that have been cleared by the agency under the premarket notification process or what’s known as 510(k) process. The FDA’s database of 510(k) premarket notifications is available for public access on the department’s official website. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. Device 510(k) Overview. FDA 510(k) Device Listing Service. After you have read the description associated with the regulation number and are absolutely certain that the product code DPW is the correct one, then go the FDA’s 510(k) database and search for any devices cleared under product code DPW.. 1-888-INFO-FDA (1-888-463-6332) Contact FDA After your device has received the final FDA 510(k) clearance and approval, your newly approved device goes into the FDA device listings database as a FDA-registered device. A 510(k) that receives an SE decision is considered "cleared." This website contains over 132,000 FDA 510(k) applications and decisions collected since May, 1976 from the U.S. Food and Drug Administration's publicly available databases of FDA Device Approvals and Clearances. Date Received: 11/06/2018: Decision Date: 01/02/2020: Decision: substantially equivalent (SESE) Regulation Medical Specialty: Anesthesiology This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. FDA adds the cleared 510(k) to the 510(k) database, which is updated weekly. 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. The FDA Device Listing process is also an annual event that happens along with the yearly Establishment Registration Fee payment. FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). 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