510(k) Report

Devices descending from K973044

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

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