FDA Product Code
FDA Product Code CAW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5440
510(k) Clearances — 289 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254289 | Portable Oxygen Concentrator (OX-1A-E, OX-1B) | Oxytek Medical Technology Co., Ltd. | 2026-09-23 | Traditional | PDF ↗ |
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | 2026-08-14 | Traditional | PDF ↗ |
| K252399 | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | 2026-06-17 | Traditional | PDF ↗ |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | 2026-05-29 | Traditional | PDF ↗ |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | 2026-04-23 | Traditional | PDF ↗ |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | 2026-03-26 | Traditional | PDF ↗ |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-12-29 | Traditional | PDF ↗ |
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-12-22 | Traditional | PDF ↗ |
| K252616 | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | 2025-12-22 | Traditional | PDF ↗ |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | 2025-12-16 | Traditional | PDF ↗ |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | 2025-12-09 | Traditional | PDF ↗ |
| K251607 | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-11-21 | Traditional | PDF ↗ |
| K243833 | Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. | 2025-09-29 | Traditional | PDF ↗ |
| K250625 | Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) | Nanjing Yinuoji Medical Technology Co., Ltd. | 2025-08-27 | Traditional | PDF ↗ |
| K251130 | Portable Oxygen Concentrator (JM-P50A) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2025-08-21 | Traditional | PDF ↗ |
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) | Caire, Inc. | 2025-07-11 | Traditional | PDF ↗ |
| K242736 | Portable Oxygen Concentrator (Spirit-3) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-06-05 | Traditional | PDF ↗ |
| K242718 | Portable Oxygen Concentrator (P2-TOC) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-02-28 | Traditional | PDF ↗ |
| K240840 | Oxygen Concentrator (ZY-10AB/115) | Foshan Care Medical Technology Co., Ltd. | 2024-12-06 | Traditional | PDF ↗ |
| K240561 | Rugged Oxygen Generator (ROG) (RO01-00001) | Molecular Products , Ltd. | 2024-12-06 | Traditional | PDF ↗ |
| K230969 | Oxygen Concentrator | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2023-11-09 | Traditional | PDF ↗ |
| K230702 | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023-10-18 | Traditional | PDF ↗ |
| K223740 | Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. | 2023-10-05 | Traditional | PDF ↗ |
| K222920 | Oxygen concentrator | Zhengzhou Olive Electronic Technology Co., Ltd. | 2023-07-20 | Traditional | PDF ↗ |
| K230052 | Inogen Rove 6 | Inogen, Inc. | 2023-06-30 | Traditional | PDF ↗ |
| K223379 | Portable Oxygen Concentrator (Model: P2-E7, P2-E) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023-06-22 | Traditional | PDF ↗ |
| K211056 | Oxus Sieve Beds | Oxus, Inc. | 2023-05-31 | Traditional | PDF ↗ |
| K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2023-04-28 | Traditional | PDF ↗ |
| K222086 | Inogen Rove 4 Portable Oxygen Concentrator | Inogen | 2022-12-09 | Traditional | PDF ↗ |
| K213210 | Oxygen Concentrator, Model JAY-5AW | Longfian Scitech Co., Ltd. | 2022-12-08 | Traditional | PDF ↗ |
| K210371 | Portable Oxygen Concentrator, model: P2-E6 | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2022-06-03 | Traditional | PDF ↗ |
| K202389 | Oxygen Concentrator | Foshan Mic Medical Technology Co., Ltd. | 2022-04-08 | Traditional | PDF ↗ |
| K203210 | Invacare Platinum 5NXG Oxygen Concentrator | Invacare Corporation | 2021-04-12 | Traditional | PDF ↗ |
| K203086 | X-PLO2R | Belluscura, LLC | 2021-03-02 | Traditional | PDF ↗ |
| K200890 | Invacare Perfecto2V Oxygen Concentrator | Invacare Corporation | 2020-08-06 | Traditional | PDF ↗ |
| K200496 | Aer X | 3B Medical, Inc. | 2020-07-24 | Special | PDF ↗ |
| K191875 | Owgels Oxygen Concentrator | Guangzhou Life Light Electronic Technology Co., Ltd. | 2020-07-20 | Traditional | PDF ↗ |
| K192693 | Nuvo Nano Portable Oxygen Concentrator | Nidek Medical Products, Inc. | 2020-05-07 | Traditional | PDF ↗ |
| K190304 | Kingon P2 Oxygen Concentrator | Qingdao Kingon Medical Science and Technology Co. | 2020-02-29 | Traditional | PDF ↗ |
| K191159 | 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 | Invacare Corporation | 2019-08-29 | Traditional | PDF ↗ |
| K180837 | CONTEC Oxygen Concentrator | Contec Medical System Co., Ltd. | 2019-01-10 | Traditional | PDF ↗ |
| K182454 | O2 Concepts Oxlife Independence Model 301-0001 | O2 Concepts, LLC | 2018-12-20 | Traditional | PDF ↗ |
| K172234 | Oxygen Concentrator | Sysmed (China) Co., Ltd. | 2018-06-01 | Traditional | PDF ↗ |
| K172648 | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator | Devilbiss Healthcare, LLC | 2018-03-23 | Traditional | PDF ↗ |
| K162433 | GCE Zen-O Portable Oxygen Concentrator | Oxus, Inc. | 2017-05-24 | Traditional | PDF ↗ |
| K160630 | Invacare Platinum Mobile Oxygen Concentrator | Invacare Corporation | 2016-09-27 | Traditional | PDF ↗ |
| K150930 | Deployable Oxygen Generation System-Smaill (DOGS-S) | Airsep Corporation | 2015-12-18 | Traditional | PDF ↗ |
| K141967 | PUREFILL OXYGEN COMPRESSOR | Inovo, Inc. | 2014-11-07 | Traditional | PDF ↗ |
| K131968 | LONGFIAN OXYGEN CONCENTRATOR | Longfian Scitech Co., Ltd. | 2014-09-05 | Traditional | PDF ↗ |
| K132489 | INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME) | Inogen, Inc. | 2014-06-20 | Traditional | PDF ↗ |
| K132205 | ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM | Inova Labs, Inc. | 2014-06-06 | Traditional | PDF ↗ |
| K134023 | 2300 SERIES MGO PORTABLE OXYGEN | Ultra Electronics Limited Precision Air & Land SY | 2014-04-25 | Traditional | PDF ↗ |
| K131990 | OXYGEN GENERATOR LIQUEFIER - (OGL) | Essex Cryogenics of Missouri, Inc. | 2014-02-21 | Traditional | PDF ↗ |
| K131016 | ROGS | Molecular Products , Ltd. | 2013-11-27 | Special | PDF ↗ |
| K123738 | MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STD | Nidek Medical Products, Inc. | 2013-02-28 | Special | PDF ↗ |
| K120785 | OMNI 3 OXYGEN SYSTEM | Caire, Inc. | 2012-10-25 | Special | PDF ↗ |
| K121260 | TROOPER OXYGEN CONCENTRATOR | Vbox, Inc. | 2012-09-21 | Traditional | PDF ↗ |
| K120566 | O2PAK OXYGEN GENERATOR | Pacific Precision Products | 2012-07-24 | Traditional | PDF ↗ |
| K121531 | A&J 5L POCA SERIES OXYGEN CONCENTRATOR | Zhongshan A&J Medical Equipment Co., Ltd. | 2012-07-17 | Traditional | PDF ↗ |
| K121167 | CAIRE COMPANION 5 OXYGEN CONCENTRATOR | Caire, Inc. | 2012-05-02 | Traditional | PDF ↗ |
| K113317 | LIFECHOICE OXYGEN CONCENTRATOR | Inova Labs, Inc. | 2011-12-28 | Special | PDF ↗ |
| K111885 | SIMPLYGO PORTABLE OXYGEN CONCENTRATOR | Respironics, Inc. | 2011-11-04 | Special | PDF ↗ |
| K103563 | PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 | Precision Medical, Inc. | 2011-07-01 | Traditional | PDF ↗ |
| K101154 | CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L | Airsep Corp. | 2011-03-28 | Traditional | PDF ↗ |
| K102750 | O2-IN-A-BOX, O2-IN-A-BOX | Geto2, Inc. | 2011-02-11 | Traditional | PDF ↗ |
| K100957 | DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION | Pacific Consolidated Industries, LLC | 2011-01-21 | Traditional | PDF ↗ |
| K100920 | MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES | Sequal Technologies Co., Ltd. | 2010-11-29 | Abbreviated | PDF ↗ |
| K102245 | CARE ZY5BA OXYGEN CONCENTRATOR | Foshan Care Medical Technology Co., Ltd. | 2010-11-09 | Traditional | PDF ↗ |
| K091716 | MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY | Merits Health Products Co., Ltd. | 2010-04-02 | Special | PDF ↗ |
| K093308 | MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD | Nidek Medical Products, Inc. | 2010-01-14 | Special | PDF ↗ |
| K092636 | POGS, MODEL 65/130 | On Site Gas Systems, Inc. | 2010-01-07 | Traditional | PDF ↗ |
| K091541 | MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES | Sequal Technologies Co., Ltd. | 2009-12-31 | Abbreviated | PDF ↗ |
| K091650 | AXS-590 SERIES | Swr International, Ltd. | 2009-11-24 | Traditional | PDF ↗ |
| K091191 | GAS TRANSFILL | Respironics Inc., Sleep & Home Respiratory Group | 2009-10-23 | Traditional | PDF ↗ |
| K083163 | OMNI 2 OXYGEN SYSTEM | Sequal Technologies, Inc. | 2009-10-20 | Traditional | PDF ↗ |
| K083559 | YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2009-09-04 | Traditional | PDF ↗ |
| K090007 | JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000 | Danyang Jumao Healthcare Equipment Co., Ltd. | 2009-07-24 | Traditional | PDF ↗ |
| K091028 | OMNI 5 TOTAL O2 DELIVERY SYSTEM | Respironics, Inc. | 2009-07-23 | Special | PDF ↗ |
| K083751 | INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 | Invacare Corporation | 2009-05-21 | Traditional | PDF ↗ |
| K082566 | MARK 5 NUVO LITE OCSI AND STD | Nidek Medical Products, Inc. | 2008-12-03 | Abbreviated | PDF ↗ |
| K072348 | PRECISION OXYGEN CONCENTRATOR | Precision Medical, Inc. | 2008-10-27 | Abbreviated | PDF ↗ |
| K081267 | HYGEIA-5 OXYGEN CONCENTRATOR | Kedl Internation Limited | 2008-09-23 | Traditional | PDF ↗ |
| K081508 | HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN | Shenyang Canta Medical Tech. Co., Ltd. | 2008-08-27 | Traditional | PDF ↗ |
| K081468 | DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES | Sunrise Medical | 2008-08-25 | Traditional | PDF ↗ |
| K081206 | HOMELOX | Respironics, Inc. | 2008-07-28 | Traditional | PDF ↗ |
| K080082 | OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS | Oxlife, LLC | 2008-04-16 | Traditional | PDF ↗ |
| K080391 | DRIVE SOLSTICE OXYGEN CONCENTRATOR | Medical Depot | 2008-03-18 | Traditional | PDF ↗ |
| K072688 | LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 | International Biophysics Corp. | 2008-01-11 | Abbreviated | PDF ↗ |
| K071608 | A&J POCA01 OXYGEN CONCENTRATOR | Zhongshan A&J Medical Equipment Co., Ltd. | 2008-01-11 | Traditional | PDF ↗ |
| K073242 | PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 | Delphi Medical Systems | 2008-01-03 | Traditional | PDF ↗ |
| K071928 | THE INVACARE FLYER, MODEL IPC 100 | Invacare Corp. | 2007-12-12 | Traditional | PDF ↗ |
| K071904 | DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M) | Carleton Life Support Systems, Inc. | 2007-10-25 | Traditional | PDF ↗ |
| K071397 | DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES | Sunrise Medical | 2007-10-01 | Special | PDF ↗ |
| K071461 | MODEL 300D HOME OXYGEN LIQUEFIER | Copd Partners, Inc. | 2007-08-21 | Traditional | PDF ↗ |
| K063454 | POGS, MODEL 33C | On Site Gas Systems, Inc. | 2007-05-09 | Traditional | PDF ↗ |
| K061414 | EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD | Pacific Consolidated Industries, LLC | 2007-01-22 | Traditional | PDF ↗ |
| K062153 | PORTABLE OXYGEN GENERATOR SYSTEM | Molecular Products , Ltd. | 2006-11-21 | Traditional | PDF ↗ |
| K061261 | L4 OXYGEN CONCENTRATOR | Respironics, Inc. | 2006-06-28 | Special | PDF ↗ |
| K060922 | OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5 | Oxlife, LLC | 2006-05-30 | Special | PDF ↗ |
| K053230 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Merits Health Products Co., Ltd. | 2006-05-16 | Traditional | PDF ↗ |
Product code CAW · Class II · Anesthesiology. Data: openFDA.