Ann: FDA Strategy and Regulatory Update, page-248

Hate to piss on your bonfire mate, because its my bonfire too, but I'm pretty certain we are a bit further back than you reckon. In the last Ann MEB stated that they were still awaiting determination on the substantive review phase, meaning that we are between the green and purple box. Between day 60 and 90 the final decision takes place, not the substantive review. We could also get hit with an additional information request soon, which could push the timeline out further. When RSH announced their 510k submission at the end of January this year they told their shareholders that generally 510k submissions take 6 months but can often take 9 months or so to clear. We are at about 5 months in so you'd be right to think that its coming soon, but in a few weeks (hopefully) not days. I might have interpreted all this wrong as the diagram the FDA put out is needlessly open to interpretation as can be seen going back through the MEB threads. Whatever the case approval is still on the cards and the waiting will probably pay off.
GLTAH