510(k) Report

Devices descending from K883591

13 later devices reach Mark-5 Concentrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032509Mark 5 Nuvo (M5C5)Nidek Medical Products, Inc.200412Class I
+2K082566Mark 5 Nuvo Lite Ocsi and STDNidek Medical Products, Inc.20081—
+2K071608A&J POCA01 Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd.20088—
+2K040892Mark 5 Nuvo Ocsi (M5C5), Models 505 and 905Nidek Medical Products, Inc.20042—
+3K123738Mark 5 Nuvo Lite Ocsi, Mark 5 Nuvo Lite STDNidek Medical Products, Inc.20130—
+3K121531A&J 5L Poca Series Oxygen ConcentratorZhongshan A&J Medical Equipment Co., Ltd.20120—
+3K102245Care ZY5BA Oxygen ConcentratorFoshan Care Medical Technology Co., Ltd.20100—
+3K090007Jumao Oxygen Concentrator, Model JM-07000HI, JM-07000I, JM-07000Danyang Jumao Healthcare Equipment Co., Ltd.20094—
+3K080391Drive Solstice Oxygen ConcentratorMedical Depot200851
+4K230969Oxygen ConcentratorJiangsu Jumao X-Care Medical Equipment Co., Ltd.20233Class I
+5K252965Oxygen Concentrator (OX-5A, OX-5C)Oxytek Medical Technology Co., Ltd.20260—
+5K253549DeVilbiss 5 Liter Oxygen Concentrator (555)Devilbiss Healthcare, LLC20260—
+5K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)Devilbiss Healthcare, LLC20250—