510(k) Report

Devices descending from K972135

22 later devices reach Maersk Medical Pureline Comfort Subcutaneous Infusion Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous…Unomedical A/S20170Class I
+1K061374Intuition Infusion SetsUnomedical A/S20062—
+1K051264Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion PumpsUnomedical A/S200511
+1K041545Contact DetachUnomedical A/S200423
+1K032485Medtronic Minimed Countach Infusion Set, Model 313Medtronic Minimed20030—
+1K032854Unomedical Monica Infusion SetUnomedical A/S2003141
+1K014062Simplicity Easy Access Infusion SetSterling Medivations, Inc.20023—
+1K984561Subcutaneous Infusion Sets, MSR Model a & BMsr, Inc.19990—
+2K242692SteadiSet Infusion SetCapillary Biomedical, LLC20251—
+2K192647neria guard Infusion SetUnomedical A/S20190—
+2K173879MiniMed Mio Advance infusion setUnomedical A/S20183—
+2K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S201614
+2K132142Neria Soft 90 Infusion SetUnomedical A/S20130—
+2K120872Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl…Unomedical A/S Infusion Devices2012110
+2K120337I-Port Advance Injection PortUnomedical A/S20120—
+2K021487Simplicity Easy Access P Infusion SetSterling Medivations, Inc.20020—
+2K020912Simplicity Easy Soft Infusion SetSterling Medivations, Inc.20021—
+3K251854SteadiSet infusion setTandem Diabetes Care20250—
+3K243841Sparta Infusion Set for InsulinDeka Research and Development20251—
+3K210544Medtronic Extended infusion setUnomedical A/S20210—
+3K021530Simplicity Easy P Soft Infusion Set for Infusion and/or Injection of Fluids Into the…Sterling Medivations, Inc.20020—
+4K261530iiSure Infusion SetDeka Research and Development20260—