FDA have approved 100% of all 510k applications in last 2 years and I dont see this one being different. The problem is that FDA is really behind on this applications. They can stretch it out for over 8 months before making a decision. There are dozens of companies that are in FDA limbo for their 510k applications. I personally like NSPH and maybe I should stop by their office and get some questions answered in person. They are only 10 minutes away from where I live.