Menstrual cup is a great option for women, and has been around for decades. With recent increasing interests by women in menstrual cups, many brands are now available on the market. However, many of these brands or sellers are giving misleading information.
Menstrual cups are considered class II medical devices and they are subject to FDA regulations. The cups can have "FDA Clearance" for sale, which went through 510(k) Premarket Notification process, and/or the cups can be "Registered with the FDA" which went through a less extensive process. All cups being available for sale in the USA are required to be FDA Cleared or FDA Registered, but few actually are.
Many brands and/or sellers claim their cups are FDA Approved, but this is actually a false claim. NO menstrual cups are "approved" by the FDA. Menstrual cups are class II devices, and the FDA only gives "Approval" to class III medical devices. "Approval" implies the cup has been tested and "approved" by the FDA, and that is just not the case for menstrual cups. There is no such thing as FDA Approved menstrual cups.
So shoppers beware! You should stay clear of cups with such claims. Look for cups that are either cleared or registered with the FDA.
This is a list of menstrual cups (15 cups) that have obtained FDA Clearance having submitted a 510(k) premarket notification :