I partially agree with you. But BIEL's products like Allay, Recover RX were already discussed and applied for 510k in the past. So, FDA should have them listed long back but not sure why sudden listing after the May 9th meeting.
Believe in your own DD. Experience: I once lost to a pumper with blind belief and the same pumper turned basher on another. Good Job!!. Moral: Do your own DD