CAW · Class II · 21 CFR 868.5440

FDA Product Code CAW: Generator, Oxygen, Portable

Leading manufacturers include Invacare Corp., Qingdao Kingon Medical Science and Technology Co., Ltd. and Healthdyne, Inc..

287
Total
287
Cleared
144d
Avg days
1976
Since
287 devices
25–48 of 287
Cleared Apr 28, 2023
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
K213825
Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.
Anesthesiology · 506d
Cleared Dec 09, 2022
Inogen Rove 4 Portable Oxygen Concentrator
K222086
Inogen
Anesthesiology · 147d
Cleared Dec 08, 2022
Oxygen Concentrator, Model JAY-5AW
K213210
Longfian Scitech Co., Ltd.
Anesthesiology · 435d
Cleared Jun 03, 2022
Portable Oxygen Concentrator, model: P2-E6
K210371
Qingdao Kingon Medical Science and Technology Co., Ltd.
Anesthesiology · 480d
Cleared Apr 08, 2022
Oxygen Concentrator
K202389
Foshan Mic Medical Technology Co., Ltd.
Anesthesiology · 595d
Cleared Apr 12, 2021
Invacare Platinum 5NXG Oxygen Concentrator
K203210
Invacare Corporation
Anesthesiology · 164d
Cleared Mar 02, 2021
X-PLO2R
K203086
Belluscura, LLC
Anesthesiology · 140d
Cleared Aug 06, 2020
Invacare Perfecto2V Oxygen Concentrator
K200890
Invacare Corporation
Anesthesiology · 125d
Cleared Jul 24, 2020
Aer X
K200496
3B Medical, Inc.
Anesthesiology · 147d
Cleared Jul 20, 2020
Owgels Oxygen Concentrator
K191875
Guangzhou Life Light Electronic Technology Co., Ltd.
Anesthesiology · 374d
Cleared May 07, 2020
Nuvo Nano Portable Oxygen Concentrator
K192693
Nidek Medical Products, Inc.
Anesthesiology · 224d
Cleared Feb 29, 2020
Kingon P2 Oxygen Concentrator
K190304
Qingdao Kingon Medical Science and Technology Co.
Anesthesiology · 382d
Cleared Aug 29, 2019
Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity
K191159
Invacare Corporation
Anesthesiology · 120d
Cleared Jan 10, 2019
CONTEC Oxygen Concentrator
K180837
Contec Medical System Co., Ltd.
Anesthesiology · 286d
Cleared Dec 20, 2018
O2 Concepts Oxlife Independence Model 301-0001
K182454
O2 Concepts, LLC
Anesthesiology · 104d
Cleared Jun 01, 2018
Oxygen Concentrator
K172234
Sysmed (China) Co., Ltd.
Anesthesiology · 311d
Cleared Mar 23, 2018
Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
K172648
Devilbiss Healthcare, LLC
Anesthesiology · 203d
Cleared Nov 04, 2011
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR
K111885
Respironics, Inc.
Anesthesiology · 126d
Cleared Jul 23, 2009
OMNI 5 TOTAL O2 DELIVERY SYSTEM
K091028
Respironics, Inc.
Anesthesiology · 104d
Cleared Jul 28, 2008
HOMELOX
K081206
Respironics, Inc.
Anesthesiology · 90d
Cleared Dec 12, 2007
THE INVACARE FLYER, MODEL IPC 100
K071928
Invacare Corp.
Anesthesiology · 153d
Cleared Jun 28, 2006
L4 OXYGEN CONCENTRATOR
K061261
Respironics, Inc.
Anesthesiology · 54d
Cleared Feb 11, 2005
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
K043006
Respironics, Inc.
Anesthesiology · 102d
Cleared Jul 23, 2002
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
K021685
Invacare Corp.
Anesthesiology · 62d