510(k) Report

Devices descending from K032509

12 later devices reach Mark 5 Nuvo (M5C5) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082566Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc.20081—
+1K071608A&J POCA01 Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd.20088—
+1K040892Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905Nidek Medical Products, Inc.20042—
+2K123738Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDNidek Medical Products, Inc.20130—
+2K121531A&J 5L Poca Series Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd.20120—
+2K102245Care ZY5BA Oxygen ConcentratorFoshan Care Medical Technology Co., Ltd.20100—
+2K090007Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000Danyang Jumao Healthcare Equipment Co., Ltd.20094—
+2K080391Drive Solstice Oxygen ConcentratorMedical Depot200851
+3K230969Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd.20233Class I
+4K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.20260—
+4K253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC20260—
+4K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)Devilbiss Healthcare, LLC20250—