510(k) Report

Devices descending from K100988

4 later devices reach Humapen Luxura HD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142518HumaPen LuxuraEli Lilly and Company20153—
+2K160668HumaPen SavvioEli Lilly and Company, Inc.20161—
+2K151686HumanPen Ergo IIEli Lilly and Company, Inc.20150—
+3K250262GO-PEN®Go-Pen Aps20250—