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 Alternate Controller Enabled Insulin Infusion Pump
510(k) Number K252770
Device Name iLet ACE Pump
Applicant
Beta Bionics, Inc.
300 Baker Ave., Suite 301
Concord,  MA  01742
Applicant Contact Liz Cooper
Correspondent
Beta Bionics, Inc.
300 Baker Ave., Suite 301
Concord,  MA  01742
Correspondent Contact Liz Cooper
Regulation Number880.5730
Classification Product Code
QFG  
Date Received09/02/2025
Decision Date 09/29/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Clinical Trials NCT04200313
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-