"Isn't it a multi-year process?" – nope. " it will take a year...

"Isn't it a multi-year process?" – nope.

" it will take a year to go through their system" – nope.

Seriously... it takes less time to do an Internet search for "fda time to approve medical device" than it takes to post your ignorance on Hotcopper!

For your convenience, such a search will turn up (among other interesting facts) this:
emergo-fda-510k-data-analysis-2017

Average time from submission to clearance in 2016 was under six months. For devices where the submission was backed by a (more expensive) third party review... under 2 months.

In any case, FDA clearance is only really critical in USA. In the other markets where we already have approval it is the study results that will prove much more important.