510(k) Report

Devices descending from K213536

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233952DEKA ACE Pump SystemDeka Research and Development20243—
+2K250930twiist systemDeka Research & Development Corp.20251—
+2K241178DEKA ACE Pump SystemDeka Research and Development20240—
+3K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and Development20260—