510(k) Report

Devices descending from K983974

7 later devices reach Owen Mumford 3ML Autopen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063151Humapen Luxura HDEli Lilly and Co.20075—
+1K993666Disetronic Pen P100Disetronic Medical Systems19990—
+2K100988Humapen Luxura HDEli Lilly and Company20104—
+3K142518HumaPen LuxuraEli Lilly and Company20153—
+4K160668HumaPen SavvioEli Lilly and Company, Inc.20161—
+4K151686HumanPen Ergo IIEli Lilly and Company, Inc.20150—
+5K250262GO-PEN®Go-Pen Aps20250—