The U.S. FDA refers to the U.S. Food and Drug Administration, which divides medical devices into the following levels according to risk:
Class I – General Monitoring
Low risk ( Such as: glasses, band-aids, etc.)
Most are exempt from 510(k)
Category II – general monitoring and special monitoring
Pre-market reporting 510(k) )
A few are exempt from 510(k)
Category III – General surveillance and premarket approval (PMA)
High risk (e.g. surgical lasers , PSA test, etc.)
No exemption
Generally, the K number we refer to refers to the 510(k) number. Enterprises need to classify the products into matching FDA medical device product classifications based on the actual ingredients, uses, applicable groups and usage methods of your products. Each product classification has its pre-market requirements, such as whether it is exempt from 510 (k). If the product is not exempt from 510(k), it must obtain a K number approved by the FDA before it can be listed as a medical device, and use a valid listing number and company registration number to enter the United States.