Not really, these days FDA is quite fast, most SE cases are...

Not really, these days FDA is quite fast, most SE cases are decided either before 90 days or just few days after, if you search 501k clearance, most of them have submitted date and clearance date which shows fews days + - 90 days. so if APAS Independence is SE to compact, it should be cleared by within 90 days with up or down few days, unless FDA has questionable on SE new product or needs DE NOVO, then it takes more than 90 days, straight forward SE medical class II devices are cleared around 90 days...