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. FDA 510(k) Device Listing Service. Searchable database of FDA 510(k) applications and descisions. The FDA’s database of 510(k) premarket notifications is available for public access on the department’s official website. This is where things can get tricky and you need to be careful. FDA adds the cleared 510(k) to the 510(k) database, which is updated weekly. According to Food, Drug, and Cosmetic Act products falling within the scope of medical devices, shall be registered in FDA database. Date Received: 11/06/2018: Decision Date: 01/02/2020: Decision: substantially equivalent (SESE) Regulation Medical Specialty: Anesthesiology 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. How to Access the FDA 510(k) Database. The FDA Device Listing process is also an annual event that happens along with the yearly Establishment Registration Fee payment. 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. 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. 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.. In that sense, FDA 510 K clearance is required for Class II devices before registration. 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). 1-888-INFO-FDA (1-888-463-6332) Contact FDA If you aim FDA 510 K Submission, the … 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. Device Classification Name: device to detect and measure procalcitonin (pct) in human clinical specimens: 510(k) Number: K160729: FOIA Releasable 510(k) This database includes: a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information. 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." What You Need to Know about FDA 510(k) Database. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. Choosing the Right Predicate Device for Your 510(k) Submission. Device 510(k) Overview. The Right Predicate Device for Your 510 ( k ) applications and descisions also an annual that. This is where things can get tricky and you need to be careful to careful... 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