510(k) Report

Devices descending from K233952

3 later devices reach DEKA ACE Pump System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250930twiist systemDeka Research & Development Corp.20251—
+1K241178DEKA ACE Pump SystemDeka Research and Development20240—
+2K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and Development20260—