510(k) Report

Devices descending from K010377

4 later devices reach Mimimed Sil-Serter Infusion Set Insertion System, Model 385 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213429AccuSert Needle InserterEmed Technologies Corporation20220—
+1K061374Intuition Infusion SetsUnomedical A/S20062—
+2K242692SteadiSet Infusion SetCapillary Biomedical, LLC20251—
+3K251854SteadiSet infusion setTandem Diabetes Care20250—