510(k) Report

Devices descending from K990801

23 later devices reach Minimed 508 Insulin Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc.20119Class I
+1K070844Nilimedix AdiNilimedix, Ltd.20080—
+1K030747Prodose Aad SystemProfile Therapeutics Plc200410—
+1K020655Deltec Insulin Infusion Pump and AccessoriesDeltec, Inc.200206
+2K141758T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc.20147—
+2K133593T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc.20148—
+2K072019AKITA2 ApixnebActivaero America, Inc.20073—
+2K042991I-Neb Aad SystemProfile Therapeutics Plc20056—
+3K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc.20164—
+3K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20161—
+3K142059Fox MobileVectura GmbH20150—
+3K143189t:flex Insulin Delivery SystemTandem Diabetes Care, Inc.20152—
+3K102454I-Neb Aad System with Tim; I-Neb Insight Aad SystemRespironics Respiratory Drug Delivery (Uk), Ltd.20110—
+3K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc.20104—
+3K090730Akita JetActivaero America, Inc.20090—
+4K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.20242—
+4K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc.20160—
+4K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc.20123—
+5K253534Pivot Insulin Delivery SystemModular Medical20261—
+5K223840eRapid Nebulizer SystemPari Respiratory Equipment, Inc.20231—
+5K162785Velox Nebulizer SystemPari Respiratory Equipment, Inc.20170—
+6K262153Pivot Insulin Delivery SystemModular Medical, Inc.20260—
+6K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.20250—