510(k) Report

Devices descending from K083163

18 later devices reach Omni 2 Oxygen System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150930Deployable Oxygen Generation System-Smaill (DOGS-S)Airsep Corporation20156—
+1K1340232300 Series Mgo Portable OxygenUltra Electronics Limited Precision Air & Land SY20140—
+1K120785Omni 3 Oxygen SystemCaire, Inc.20129—
+2K251764Oxygen Concentrator-P2-O5EQingdao Kingon Medical Science and Technology Co., Ltd.20250—
+2K242718Portable Oxygen Concentrator (P2-TOC)Qingdao Kingon Medical Science and Technology Co., Ltd.20251—
+2K222920Oxygen concentratorZhengzhou Olive Electronic Technology Co., Ltd.20233—
+2K172234Oxygen ConcentratorSysmed (China) Co., Ltd.20180—
+2K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc.20176Class I
+3K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)Shenzhen Harveymed Technology Co., Ltd.20250—
+3K240840Oxygen Concentrator (ZY-10AB/115)Foshan Care Medical Technology Co., Ltd.20242—
+3K181166Trilogy EvoRespironics, Inc.20195Class I
+4K251534Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd.20250—
+4K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.20250—
+4K251607Oxygen Concentrator (J5A)Foshan Kycare Medical Equipment Co., Ltd.20250—
+4K241135RESPOND (R) VentilatorCorvent Medical, Inc.20240—
+4K240807VM-2000Ventis Medical, Inc.20240—
+4K193586Vivo 45 LSBreas Medical AB20212Class I
+5K233452Vivo 45 LSBreas Medical AB202501