From https://www.emergogroup.com/blog/20...510k-submissions-us-medical-device-firms-2015
Although (or perhaps because) the FDA cleared fewer 510(k) submissions in 2015 than in previous years, the agency did so at a slightly faster rate: 22% of premarket notification applications were cleared within three months of submission, and 61% of applications were cleared within six months. Within nine months of submission, 86% of applications received FDA clearance, while 95% of applications were cleared within 12 months.
More information on review times.
http://www.emergogroup.com/resources/research/fda-510k-review-times-research
And a calculator here:
http://www.emergogroup.com/resources/united-states/fda-510k-calculator
But I can't seem to find the APAS code. Had a brief look here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
FDA Approval, page-2
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