510(k) Report

Devices descending from K905693

28 later devices reach H-Tron V 100 Insulin Infusion Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973044Disetronic H-Tron Plus V 100 Insulin Infusion PumpDisetronic Medical Systems1997275
+2K023471Disetronic H-Tronplus Insulin Infusion PumpDisetronic Medical Systems AG200201
+2K013309Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc.2002121
+2K994186Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems19996—
+2K991376Dahedi Insulin Infusion PumpDisetronic Medical Systems199901
+2K982966Disetronic PenDisetronic Medical Systems19984—
+3K100567Pearl Diabetes Management SystemM2 Group Holdings, Inc.20112—
+3K083457TactipenHaselmeier GmbH20090—
+3K070100Haselmeier PenHaselmeier Sarl20072—
+3K050312Amigo Insulin PumpNipro Diabetes Systems, Inc.200511—
+3K022831Modification to Disetronic D-Tronplus Insulin Infusion PumpDisetronic Medical Systems AG200241
+3K021725Disetronic D-Tron Insulin Infusion PumpDisetronic Medical Systems AG20025—
+3K993666Disetronic Pen P100Disetronic Medical Systems19990—
+4K122483Pearl Diabetes Management SystemAsante Solutions, Inc.20131—
+4K082616Haselmeier Pen 8Haselmeier GmbH20080—
+4K071613Amigo Insulin PumpNipro Diabetes Systems, Inc.200710—
+4K043000Modification to D-TronplusDisetronic Medical Systems AG200432
+5K142619Snap Insulin Pump SystemAsante Solutions, Inc.20140—
+5K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc.20119Class I
+6K141758T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc.20147—
+6K133593T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc.20148—
+7K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc.20164—
+7K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20161—
+7K143189t:flex Insulin Delivery SystemTandem Diabetes Care, Inc.20152—
+8K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.20242—
+8K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20160—
+9K253534Pivot Insulin Delivery SystemModular Medical20261—
+10K262153Pivot Insulin Delivery SystemModular Medical, Inc.20260—