• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name continuous glucose monitor informed insulin dose calculator
510(k) Number K203772
Device Name Omnipod 5 SmartBolus Calculator
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Applicant Contact Julie Perkins
Insulet Corporation
100 Nagog Park
Acton,  MA  01720
Correspondent Contact Julie Perkins
Regulation Number862.1358
Classification Product Code
Subsequent Product Code
Date Received12/23/2020
Decision Date 01/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No