510(k) Report

Devices descending from K994428

11 later devices reach E7512 Premie Rem Polyhesive II Patient Return Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160290Valleylab REM Polyhesive Infant Patient Return ElectrodeCovidien, LLC20160—
+1K140500SkintactLeonhard Lang GmbH20144—
+1K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc.20084Class I
+2K173877BOWA Neutral ElectrodesBowa-Electronics GmbH & Co. KG20183—
+2K133726Mega Soft Universal Patient Return ElectrodeMegadyne Medical Products, Inc.20143Class I
+3K233644Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient…Megadyne Medical Products, Inc.20240Class I
+3K231985Disposable Grounding PadShenzhen Mecun Medical Supply Co., Ltd.20240—
+3K210727HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC202202
+3K203494Nissha Medical Technologies Neutral ElectrodesNissha Medical Technologies, Ltd.20211—
+3K183148OKLand Patient Return Electrode PadAuckland Medical Polymer (Tianjin) Co., Ltd.20200—
+4K242204Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A…Dongguan Quanding Medical Supplies Co., Ltd.20240—