510(k) Report

Devices descending from K002138

3 later devices reach Paradigm Silhouette, Models MMT-377, 378, 379, 380 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S201614
+1K032484Medtronic Minimed Paradigm Countach Infusion Set, Model MMT 310Medtronic Minimed20030—
+2K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous…Unomedical A/S20170Class I