kBLASTER is a browser based Software as a Service (SaaS) that searches the entire contents of the publicly available summary 510(k) data for all 510(k)s that received clearance from the Food and Drug Administration (FDA). Regulatory and device development professionals use kBLASTER to find primary predicate, multiple predicates, reference device, biocompatiblity or any other actionable insight matches in order to establish substantial equivalence for a 510(k) submission to the FDA.
A primary predicate is the previously 510(k) cleared medical device that most closely matches your proposed device in terms of intended use, indications for use and technological characteristics. Establishing substantial equivalence by appropriate predicate selection has always been an essential component to a successful 510(k) submission, but per July 2014 final guidance from the FDA that recommends the identification of a single primary predicate in a 510(k) submission its more critical than ever.
kBLASTER allows you to search the entire contents of more than 60,000 publicly available 510(k) summaries and more than 76,000 510(k) splash pages. With a focus on data science, kBLASTER offers multiple search and sorting options, including tools to view and manage valued search hits with My Favorites, as well as saving searches of interest with Saved Search. For more detail, please click here to go to Support Page to review the Search Tips tutorial video or click here to go to Search page to review clickable Search Tips.
kBLASTER will update its database monthly with newly-cleared 510(k) summary data, then automatically run your Saved Searches and send an Alert email if a new Saved Search hit is found. Upon entering your active kBLASTER account, notification flags will indicate any Saved Searches that have new hits. Regardless of whether you use the Save Search function, all of your searches will be retained in the Search History section, so you'll never lose any previously performed searches.
Yes. kBLASTER runs on smartphones, tablets or computers using a standard web browser. Search and manage results in one place, using whatever device is convenient.
kBLASTER can be purchased for a recurring monthly subscription of $79.99 per month via a secure socket layer (SSL) gateway with all major credit cards: Visa, Mastercard, American Express and Discover. Click here to buy kBLASTER for an unparalleled search and sorting experience, using a full suite of tools including My Favorites, Saved Search with Alert notifications and Search History.
If your credit card information has expired and does not allow a recurring monthly purchase, Buy another subscription using your email address and password on record to enter your new credit card information and regain access to your account. All of your kBLASTER Search History, Saved Searches and My Favorites will be waiting for you.
Go to your My Account page and click Recurring Subscriptions, where you can manage monthly recurring subscription information by updating your credit card information if needed and cancel a monthly recurring subscription if desired.
We have 25 years experience navigating FDA 510(k) clearance strategy and are ready to put our skills to work for you. Click here to contact kBLASTER and set up a customized work proposal to get on the path of 510(k) clearance success.