510(k) Report

Devices descending from K032854

14 later devices reach Unomedical Monica Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192647neria guard Infusion SetUnomedical A/S20190—
+1K173879MiniMed Mio Advance infusion setUnomedical A/S20183—
+1K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S201614
+1K132142Neria Soft 90 Infusion SetUnomedical A/S20130—
+1K120872Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl…Unomedical A/S Infusion Devices2012110
+1K120337I-Port Advance Injection PortUnomedical A/S20120—
+1K061374Intuition Infusion SetsUnomedical A/S20062—
+1K051264Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion PumpsUnomedical A/S200511
+2K243841Sparta Infusion Set for InsulinDeka Research and Development20251—
+2K242692SteadiSet Infusion SetCapillary Biomedical, LLC20251—
+2K210544Medtronic Extended infusion setUnomedical A/S20210—
+2K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous…Unomedical A/S20170Class I
+3K261530iiSure Infusion SetDeka Research and Development20260—
+3K251854SteadiSet infusion setTandem Diabetes Care20250—