What are some of the criticisms and concerns that have been raised about the 510(k) clearance pathway?

Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance. JAMA. 2023 Jan 10; ... Public documents for the 510(k) medical devices were collected using FDA ... 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 ... The FDA's 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 ... Jan 16, 2001 ... Because FDA may be unaware that ownership of a 510(k) has changed, the notification by Internet site would serve as an additional means of ... Aug 12, 2021 ... When a medical device is cleared, this means it has undergone a 510(k) submission, which the FDA has reviewed and provided clearance. For Class ... Jan 30, 2023 ... ... dose concerns mean CT is not optimal. Adaptix's central mission is to transform radiology by offering affordable low-dose 3D imaging at the ... Aug 4, 2022 ... “When Xoran states that TRON is the 'One RING to rule them all,' we truly mean that this compact, mobile, open-bore device is poised to ... Jan 7, 2025 ... This new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve and is specifically designed so that it can ... any medical devices require 510(k) clear- ance or premarket application (PMA) approval from FDA prior to commercial distribution. A firm that is purchasing ... Jul 3, 2024 ... What exactly does this mean? I have heard this tossed around for some time and want to learn more about the specifics of a FDA 510(k) ...