510(k) Report

Devices descending from K021077

6 later devices reach Mega 2000 Soft Patient Return Electrode Pad through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080741Mega Soft Reusable Patient Return ElectrodeMegadyne Medical Products, Inc.20084Class I
+1K031285Mega 2000 Soft Dual Cord Patient Return Electrode PadMegadyne Medical Products, Inc.20035Class I
+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
+3K210727HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC202202
+3K183148OKLand Patient Return Electrode PadAuckland Medical Polymer (Tianjin) Co., Ltd.20200—