What is a predicate device in the context of 510(k) clearance?

Leading letter “K” indicates 510(k) clearance, or Premarket Notification. This is an .exact field. It has been indexed both as its exact string content, and ... Nov 20, 2024 ... “THINK Surgical is excited to add the MOBIO™ Total Knee System to the TMINI System. The open platform version of TMINI is now available with ... Jan 17, 2023 ... Henry further said it's important to keep in mind that the definition of “recall” is broad and doesn't necessarily mean a product was so ... Jan 29, 2025 ... 2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person's bloodstream (serum and plasma), and will be broadly available on ... Feb 4, 2025 ... FDA clearance through the 510(k) process means the agency agrees ... What does it mean to be 510(k) exempt? Some medical devices are ... Feb 14, 2025 ... The goal of the 510(k) submission is to demonstrate that the device is "substantially equivalent" to a device that has already been cleared by ... Mar 17, 2025 ... What does the FDA 510(k) clearance mean for Monogram's mBôs TKA System (MGRM)?. The clearance allows Monogram to legally market and sell ... TPRG specializes in the review of 510(k) submissions, providing you with efficient FDA clearance. The Third Party Review Group is the expert in 510K TPR ... Mar 17, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, "This FDA 510(k) clearance is a defining moment for Monogram ... 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 ...