510(k) Report

Devices descending from K061261

6 later devices reach L4 Oxygen Concentrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5AJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20230—
+1K132489Inogen at Home Oxygen Concentrator (Aka Inogen at Home)Inogen, Inc.20140—
+1K132205Actovox DUO2 Oxygen Concentrator SystemInova Labs, Inc.20140—
+1K082566Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc.20081—
+1K072348Precision Oxygen ConcentratorPrecision Medical, Inc.20080—
+2K123738Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDNidek Medical Products, Inc.20130—