Emergo Group performed an analysis of publicly available FDA 510(k) data pulled from the FDA website on 15 January 2013. Data was pulled for the time period 1 January 2006 through 31 December 2011. Total number of records analyzed was 18,615. All data was sorted by the date FDA received a 510(k) submission, not the date it was cleared. Thus, 2010 data, for example, shows the statistics for all 510(k) submissions received by the FDA between 1 January 2010 and 31 December 2010. We only analyzed data for 510(k) submissions through the end of 2011 to allow a full 12 months for FDA 510(k) submissions to be cleared. Our analysis has shown that 95-97% of all 510(k) applications cleared by the FDA occur within one year of initial submission date.