Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 Set, Administration, Intravascular
510(k) Number K251854
Device Name SteadiSet infusion set
Applicant
Tandem Diabetes Care
12400 High Bluff Dr.
San Diego,  CA  92130
Applicant Contact Karen Mudd
Correspondent
Tandem Diabetes Care
12400 High Bluff Dr.
San Diego,  CA  92130
Correspondent Contact Karen Mudd
Regulation Number880.5440
Classification Product Code
FPA  
Date Received06/17/2025
Decision Date 08/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-