What are the implications of changes to the predicate device after a new device has been cleared based on that predicate?

Apr 17, 2025 ... This 510(k) clearance is a testament to years of effort, and we are excited to bring this groundbreaking technology to physicians and their ... Feb 9, 2025 ... “Prostate cancer is one of the most prevalent cancers worldwide, with an estimated one in eight men diagnosed in their lifetime. With the global ... The 510(k) pathway allows the clearance of a new medical device if the manufacturer shows that the device is substantially equivalent to one or more legally ... Jun 5, 2024 ... A legally marketed predicate means the device has previously gone through a 510(k) clearance process and obtained FDA clearance or was on the ... What is an Ebook? Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared ... Jan 24, 2023 ... What does this all mean for you? It means we did the work to ... What that means: A 510(k) filing contains detailed technical, safety ... Apr 16, 2017 ... FDA's analysis of whether to exempt a type of device from the 510(k) requirements is specific to the devices within the generic category in ... The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of ... Dec 30, 2024 ... SIMEOX 200 is predominantly aimed to help patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as ... Apr 11, 2023 ... A 510(k) clearance means that FDA has completed its review of the 510(k) review and determined that the device is substantially equivalent to an ...