510(k) Report

Devices descending from K120785

9 later devices reach Omni 3 Oxygen System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242718Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd.20251—
+1K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+2K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd.20250—
+2K181166Trilogy EvoRespironics, Inc.20195Class I
+3K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+3K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+3K240807VM-2000Ventis Medical, Inc.20240—
+3K193586Vivo 45 LSBreas Medical AB20212Class I
+4K233452Vivo 45 LSBreas Medical AB202501