Hi all,
I understand a lot of people may be following the 90 day submission guidelines posted by the FDA but after a quick historical check on Atcor's previous 510k submissions it seems even when the application runs smoothly it can still take longer than expected. Atcor's historical data is below:
Sphygmocor Xcel submitted 18/07/12, approved 16/11/12 - 4 months
Sphygmocor cardiovascular management system submitted 22/03/07, approved 31/08/07 - 5months
Sphygmocor PX model scor-PX submitted 02/08/01, approved 21/02/02 - 6 months
Ultra Cuff blood pressure cuff and inflation bag submitted 13/09/95, approved 06/02/96 - 5 months.
Furthermore, the 510k submissions that have been approved so far in 2022 have taken anywhere between 2 months to 2 years for the final decision. This data is easily found on the FDA website if anyone wants to browse.
A lot has also changed since these past submissions, however I still believe we are on the right tract, CC has all his ducks lined up and we need to be patient and trust in his skill and confidence and amazing team he has secured. CC did mention up to 6 months for the expected decision from FDA I believe. I'm looking forward to the next game changing 12 months.
All is well in the Cardiex/Conneqt world...
AIMO
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