ClearanceBrief
Panels › Anesthesiology › Product code CAW · Class 2

Generator, Oxygen, Portable

Regulation 868.5440

12510(k)s in 12 months (289 all time)
2recalls in 12 months (44 all time)
35recalls that name a 510(k)
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Top companies in CAW

Company510(k)sRecalls
Invacare Corp.205
Nidek Medical Products, Inc.79
Mountain Medical Equipment, Inc.120
Caire, Inc.47
Airsep Corp.80
The John Bunn Co.80
On Site Gas Systems, Inc.71
Sequal Technologies Co., Ltd.61
Devilbiss Healthcare, LLC33
Merits Health Products Co., Ltd.60
Decided510(k)Device and applicantCode
Sep 23, 2026K254289Portable Oxygen Concentrator (OX-1A-E, OX-1B)
Oxytek Medical Technology Co., Ltd., CN
CAW
Aug 14, 2026K260171Portable Oxygen Concentrator (PO1 5B, PO1 6B)
BMC Medical Co., Ltd., CN
CAW
Jun 17, 2026K252399Portable Oxygen Concentrator
Honsun (Nantong) Co., Ltd., CN
CAW
May 29, 2026K252965Oxygen Concentrator (OX-5A, OX-5C)
Oxytek Medical Technology Co., Ltd., CN
CAW
Apr 23, 2026K252407OxyGo Portable Oxygen Concentrator (1400-7000)
Mv Life, LLC
CAW
Mar 26, 2026K253549DeVilbiss 5 Liter Oxygen Concentrator (555)
Devilbiss Healthcare, LLC
CAW
Dec 29, 2025K251534Oxygen Concentrator (J10A)
Foshan Kycare Medical Equipment Co., Ltd., CN
CAW
Dec 22, 2025K252616Portable oxygen concentrator (JLO-190P)
Shenzhen Homed Medical Device Co., Ltd., CN
CAW
Dec 22, 2025K251764Oxygen Concentrator-P2-O5E
Qingdao Kingon Medical Science and Technology Co., Ltd., CN
CAW
Dec 16, 2025K252268V series portable oxygen concentrator (V5, V5C, V6, V6C)
Shenzhen Harveymed Technology Co., Ltd., CN
CAW
Dec 9, 2025K250805DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
Devilbiss Healthcare, LLC
CAW
Nov 21, 2025K251607Oxygen Concentrator (J5A)
Foshan Kycare Medical Equipment Co., Ltd., CN
CAW
Sep 29, 2025K243833Portable oxygen concentrator (JAY-1000P)
Longfian Scitech Co., Ltd., CN
CAW
Aug 27, 2025K250625Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); P
Nanjing Yinuoji Medical Technology Co., Ltd., CN
CAW
Aug 21, 2025K251130Portable Oxygen Concentrator (JM-P50A)
Jiangsu Jumao X-Care Medical Equipment Co., Ltd., CN
CAW
Jul 11, 2025K250671FreeStyle Comfort (AS200 / FreeStyle Comfort)
Caire, Inc.
CAW
Jun 5, 2025K242736Portable Oxygen Concentrator (Spirit-3)
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
CAW
Feb 28, 2025K242718Portable Oxygen Concentrator (P2-TOC)
Qingdao Kingon Medical Science and Technology Co., Ltd., CN
CAW
Dec 6, 2024K240840Oxygen Concentrator (ZY-10AB/115)
Foshan Care Medical Technology Co., Ltd., CN
CAW
Dec 6, 2024K240561Rugged Oxygen Generator (ROG) (RO01-00001)
Molecular Products , Ltd., GB
CAW
Nov 9, 2023K230969Oxygen Concentrator
Jiangsu Jumao X-Care Medical Equipment Co., Ltd., CN
CAW
Oct 18, 2023K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
Qingdao Kingon Medical Science and Technology Co., Ltd., CN
CAW
Oct 5, 2023K223740Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd., CN
CAW
Jul 20, 2023K222920Oxygen concentrator
Zhengzhou Olive Electronic Technology Co., Ltd., CN
CAW
Jun 30, 2023K230052Inogen Rove 6
Inogen, Inc.
CAW
Jun 22, 2023K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)
Qingdao Kingon Medical Science and Technology Co., Ltd., CN
CAW
May 31, 2023K211056Oxus Sieve Beds
Oxus, Inc.
CAW
Apr 28, 2023K213825Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
CAW
Dec 9, 2022K222086Inogen Rove 4 Portable Oxygen Concentrator
Inogen
CAW
Dec 8, 2022K213210Oxygen Concentrator, Model JAY-5AW
Longfian Scitech Co., Ltd., CN
CAW
Jun 3, 2022K210371Portable Oxygen Concentrator, model: P2-E6
Qingdao Kingon Medical Science and Technology Co., Ltd., CN
CAW
Apr 8, 2022K202389Oxygen Concentrator
Foshan Mic Medical Technology Co., Ltd., CN
CAW
Apr 12, 2021K203210Invacare Platinum 5NXG Oxygen Concentrator
Invacare Corporation
CAW
Mar 2, 2021K203086X-PLO2R
Belluscura, LLC
CAW
Aug 6, 2020K200890Invacare Perfecto2V Oxygen Concentrator
Invacare Corporation
CAW
Jul 24, 2020K200496Aer X
3B Medical, Inc.
CAW
Jul 20, 2020K191875Owgels Oxygen Concentrator
Guangzhou Life Light Electronic Technology Co., Ltd., CN
CAW
May 7, 2020K192693Nuvo Nano Portable Oxygen Concentrator
Nidek Medical Products, Inc.
CAW
Feb 29, 2020K190304Kingon P2 Oxygen Concentrator
Qingdao Kingon Medical Science and Technology Co., CN
CAW
Aug 29, 2019K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth D
Invacare Corporation
CAW
Jan 10, 2019K180837CONTEC Oxygen Concentrator
Contec Medical System Co., Ltd., CN
CAW
Dec 20, 2018K182454O2 Concepts Oxlife Independence Model 301-0001
O2 Concepts, LLC
CAW
Jun 1, 2018K172234Oxygen Concentrator
Sysmed (China) Co., Ltd., CN
CAW
Mar 23, 2018K172648Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
Devilbiss Healthcare, LLC
CAW
May 24, 2017K162433GCE Zen-O Portable Oxygen Concentrator
Oxus, Inc.
CAW
Sep 27, 2016K160630Invacare Platinum Mobile Oxygen Concentrator
Invacare Corporation
CAW
Dec 18, 2015K150930Deployable Oxygen Generation System-Smaill (DOGS-S)
Airsep Corporation
CAW
Nov 7, 2014K141967PUREFILL OXYGEN COMPRESSOR
Inovo, Inc.
CAW
Sep 5, 2014K131968LONGFIAN OXYGEN CONCENTRATOR
Longfian Scitech Co., Ltd.
CAW
Jun 20, 2014K132489INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
Inogen, Inc.
CAW

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