510(k) Report

Devices descending from K063151

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100988Humapen Luxura HDEli Lilly and Company20104—
+2K142518HumaPen LuxuraEli Lilly and Company20153—
+3K160668HumaPen SavvioEli Lilly and Company, Inc.20161—
+3K151686HumanPen Ergo IIEli Lilly and Company, Inc.20150—
+4K250262GO-PEN®Go-Pen Aps20250—