Hi Carol,
Product Code CAE is, in fact, exempt from 510(k), but remember, subject to the limitations in 868.9. There isn't any 510(k) Summary provided on FDA's website for K130304 (probably the 510(k) you noticed).
I found that device's indications for use, patient population, use environment, technology, etc. in K142103. I encourage you to take a look, as it may give you clues about why the product exceeded the limitations of the premarket notification waiver.
Note, now that this device (the one that exceeded the limitations of the exemption) is cleared, other similar devices do not require a 510(k).
John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
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Original Message------
Hi,
I am researching laryngeal masks. They fall under pro code CAE, which is class I exempt but 510(k)s were filed as recently as 2013. Can you please tell me FDA requires a 510(k) for laryngeal masks?
Thanks!
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Carol Vierling RAC
President
Warsaw IN
United States
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