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U.S. Department of Health and Human Services

For Consumers

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FDA-Cleared Diabetes Devices

 

Premarket Notification 510(k) Cleared Medical Devices for the Management of Diabetes 

Most medical devices used to manage diabetes either measure glucose levels in the blood or urine or deliver insulin. These types of devices are regulated through FDA’s Premarket Notification or 510(k) process. To acquire clearance to market, a device using the 510(k) pathway, a company must show that the medical device is “substantially equivalent” to a device that is already marketed legally for the same use.
 
 
Instructions on how to use the 510(k) database:
  • Open the 510(k) database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
  • In the 4th box from the top, Device Name, enter either Glucose or Insulin or Infusion Sets 
  • Leave all other boxes empty
  • Click on the button marked Search at the bottom right of the page
  • Select a product on the list for additional information