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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K053229 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Merits Health Products Co., Ltd. | 2006-03-23 | Special | PDF ↗ |
| K053240 | DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES | Sunrise Medical | 2006-02-03 | Traditional | PDF ↗ |
| K052396 | OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615 | Oxysure Systems, Inc. | 2005-12-09 | Traditional | PDF ↗ |
| K043520 | EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR | Emg Technology Co., Ltd. | 2005-10-21 | Abbreviated | PDF ↗ |
| K033405 | LONGFEI LFY-I-5 OXYGEN CONCENTRATOR | Zhejiang Longfei Industrial Co., Ltd. | 2005-10-18 | Traditional | PDF ↗ |
| K051887 | PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) | Carleton Life Support Systems, Inc. | 2005-09-27 | Traditional | PDF ↗ |
| K033863 | OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03 | Ox-Gen, Inc. | 2005-08-22 | Traditional | PDF ↗ |
| K050430 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR | Merits Health Products Co., Ltd. | 2005-08-04 | Traditional | PDF ↗ |
| K042944 | HOME-AWAY SYSTEM, MODEL 1041 | In-X Corporation | 2005-04-15 | Traditional | PDF ↗ |
| K043006 | MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 | Respironics, Inc. | 2005-02-11 | Abbreviated | PDF ↗ |
| K043615 | OXYTEC, MODEL 900 | Oxytec Medical Corporation | 2005-02-09 | Traditional | PDF ↗ |
| K042262 | INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 | Sequal Technologies, Inc. | 2004-09-10 | Special | PDF ↗ |
| K041664 | PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C | On Site Gas Systems, Inc. | 2004-07-29 | Traditional | PDF ↗ |
| K032818 | INOGEN ONE OXYGEN CONCENTRATOR | Inogen, Inc. | 2004-05-13 | Traditional | PDF ↗ |
| K040738 | MOBILE OXYGEN STORAGE TANK (MOST) | Pacific Consolidated Industries Llp | 2004-04-30 | Traditional | PDF ↗ |
| K040892 | MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905 | Nidek Medical Products, Inc. | 2004-04-29 | Special | PDF ↗ |
| K032509 | MARK 5 NUVO (M5C5) | Nidek Medical Products, Inc. | 2004-03-18 | Traditional | PDF ↗ |
| K030920 | POGS 33 | On Site Gas Systems, Inc. | 2004-03-10 | Traditional | PDF ↗ |
| K030233 | TRAVELSOME STANDARD | Sim Italia S.R.L. | 2003-04-25 | Special | PDF ↗ |
| K022684 | PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS) | Essex Cryogenics of Missouri, Inc. | 2002-09-11 | Abbreviated | PDF ↗ |
| K021685 | VENTURE HOMEFILL II WITH OXYGEN CONSERVER | Invacare Corp. | 2002-07-23 | Traditional | PDF ↗ |
| K020386 | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 | Invacare Corp. | 2002-07-02 | Traditional | PDF ↗ |
| K021082 | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 | On Site Gas Systems, Inc. | 2002-05-22 | Traditional | PDF ↗ |
| K020330 | DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS) | Pacific Consolidated Industries Llp | 2002-04-12 | Abbreviated | PDF ↗ |
| K013931 | OMNI OXYGEN SYSTEM, MODEL 1000 | Sequal Technologies, Inc. | 2002-03-27 | Traditional | PDF ↗ |
| K020324 | LIFESTYLE OXYGEN CONCENTRATOR | Airsep Corp. | 2002-03-13 | Traditional | PDF ↗ |
| K020362 | P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM | On Site Gas Systems, Inc. | 2002-02-12 | Traditional | PDF ↗ |
| K014301 | MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Merits Health Products Co., Ltd. | 2002-02-11 | Special | PDF ↗ |
| K013223 | PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS) | Litton Systems, Inc. | 2002-02-11 | Traditional | PDF ↗ |
| K012037 | HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009 | Airsep Corp. | 2002-01-17 | Traditional | PDF ↗ |
| K014078 | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM | On Site Gas Systems, Inc. | 2002-01-08 | Traditional | PDF ↗ |
| K004047 | HOME-AWAY SYSTEM | In-X Corp. | 2001-12-18 | Traditional | PDF ↗ |
| K013472 | TOTAL O2 | Chad Therapeutics, Inc. | 2001-11-28 | Traditional | PDF ↗ |
| K011844 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Merits Health Products., Inc. | 2001-08-28 | Traditional | PDF ↗ |
| K003472 | INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM | Sequal Technologies, Inc. | 2001-06-04 | Traditional | PDF ↗ |
| K003939 | VENTURE HOME FILL II, MODEL IOH 200 | Invacare Corp. | 2001-03-21 | Traditional | PDF ↗ |
| K991722 | DEVILBISS 5 LITER OXYGEN CONCENTRATOR | Sunrise Medical Hhg, Inc. | 1999-11-03 | Traditional | PDF ↗ |
| K983627 | VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM | Invacare Corp. | 1999-10-22 | Traditional | PDF ↗ |
| K993088 | PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI | Puritan Bennett Corp. | 1999-10-08 | Special | PDF ↗ |
| K981047 | FRESH AIR | Colorado Medtech, Inc. | 1999-09-16 | Traditional | PDF ↗ |
| K991569 | HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2 | 02 Marketing Group, Inc. | 1999-08-03 | Traditional | PDF ↗ |
| K984081 | EMOX | Emox 911 CC | 1999-03-17 | Traditional | PDF ↗ |
| K983777 | MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM | Invacare Corp. | 1998-12-18 | Traditional | PDF ↗ |
| K982243 | CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615 | Canogen International , Ltd. | 1998-11-19 | Traditional | PDF ↗ |
| K981078 | TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000 | Transtracheal Systems | 1998-07-23 | Traditional | PDF ↗ |
| K972614 | TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605 | Healthdyne Technologies, Inc. | 1998-01-20 | Traditional | PDF ↗ |
| K971889 | CHAD TOTAL O2 DELIVERY SYSTEM | Chad Therapeutics, Inc. | 1997-11-17 | Traditional | PDF ↗ |
| K971947 | INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY) | Sim Italia S.R.L. | 1997-10-03 | Traditional | PDF ↗ |
| K971964 | OXLIFE EXCELL OXYGEN CONCENTRATORS | Oxlife, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K971129 | OXYPURE PORTABLE OXYGEN GENERATOR | Arbor Research Corp. | 1997-06-24 | Traditional | PDF ↗ |
| K960309 | AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) | Airsep Corp. | 1997-02-28 | Traditional | PDF ↗ |
| K963042 | INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 | Sim Italia S.R.L. | 1996-11-01 | Traditional | PDF ↗ |
| K954506 | EMOX | Medtrak Intl., Inc. | 1996-04-30 | Traditional | PDF ↗ |
| K955549 | OXLIFE OXYGEN CONCENTRATORS | Oxlife, Inc. | 1996-03-15 | Traditional | PDF ↗ |
| K952941 | SUN MODEL OA 3000 OXYGEN ANALYZER | Sun Medical Equipment, Inc. | 1996-01-29 | Traditional | PDF ↗ |
| K954271 | WESTMED CONDESATE COLLECTION TRAP | Westmed Intl. | 1995-12-28 | Traditional | PDF ↗ |
| K953815 | 5 LPM OXYGEN CONCENTRATOR | Devilbiss Health Care, Inc. | 1995-11-09 | Traditional | PDF ↗ |
| K953949 | HUMIDIFIER & ACCESSORIES | Fisher & Paykel Electronics , Ltd. | 1995-10-16 | Traditional | PDF ↗ |
| K951882 | ECO CHECK (ECOVALVE AND OXYGEN MONITOR) | Airsep Corp. | 1995-10-16 | Traditional | PDF ↗ |
| K941145 | OXY-GENERATOR | Med Systems | 1995-09-27 | Traditional | PDF ↗ |
| K952037 | 3 LPM OXYGEN CONCENTRATOR | Devilbiss Health Care, Inc. | 1995-09-06 | Traditional | PDF ↗ |
| K952268 | MODEL DELTA, OM OXYGEN CONCENTRATOR | Caire, Inc. | 1995-08-11 | Traditional | PDF ↗ |
| K942082 | MODEL 6323 OXYGEN CONCENTRATOR | Dynotec Corp. | 1994-12-08 | Traditional | PDF ↗ |
| K933081 | OXLIFE OXYGEN CONCENTRATOR | Oxlife, Inc. | 1994-11-01 | Traditional | PDF ↗ |
| K924565 | SBS MODEL 1615 | Stand-By-Systems, Inc. | 1994-09-09 | Traditional | PDF ↗ |
| K935370 | MINIOX IA OXYGEN ANALYZER | Minesafety Appliances Co. | 1994-08-02 | Traditional | PDF ↗ |
| K942357 | H-500 ALLIANCE OXYGEN CONCENTRATOR | Healthdyne, Inc. | 1994-05-27 | Traditional | PDF ↗ |
| K931355 | WHISPER O2 | Trilogic Corp. | 1994-03-25 | Traditional | PDF ↗ |
| K924818 | MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES | Invacare Corp. | 1993-08-06 | Traditional | PDF ↗ |
| K924152 | KEYSTONE CONCENTRATOR, MODEL PV5L | Devilbiss Health Care, Inc. | 1993-06-07 | Traditional | PDF ↗ |
| K924100 | OXYGEN CONCENTRATOR | Allied Healthcare Products, Inc. | 1993-03-19 | Traditional | PDF ↗ |
| K923650 | SCOTTY | Mountain Medical Equipment, Inc. | 1993-01-15 | Traditional | PDF ↗ |
| K924146 | OH-500 OXYGEN CONCENTRATOR | Healthdyne, Inc. | 1993-01-07 | Traditional | PDF ↗ |
| K914916 | ALPINE V | Mountain Medical Equipment, Inc. | 1992-09-23 | Traditional | PDF ↗ |
| K914488 | MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS | Invacare Corp. | 1992-09-15 | Traditional | PDF ↗ |
| K915381 | PORTABLE OXYGEN GENERATOR | Aequitron Medical, Inc. | 1992-03-11 | Traditional | PDF ↗ |
| K912794 | ECONOMATE/PATRIOT | Foothills Medical Equipment, Inc. | 1992-02-21 | Traditional | PDF ↗ |
| K913327 | CONTEMPRO2 HOME HEALTH CARE REGULATOR | Continental Products, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K904639 | GENOX MODEL CT-1 | Pacific Consolidated Industries | 1991-08-13 | Traditional | PDF ↗ |
| K901712 | GUILD MAXOX GENERATOR (MAXOX) | Guild Assoc., Inc. | 1991-02-27 | Traditional | PDF ↗ |
| K904087 | MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON | Invacare Corp. | 1990-10-26 | Traditional | PDF ↗ |
| K903608 | V-LINK | GE Medical Systems | 1990-10-12 | Traditional | PDF ↗ |
| K904271 | OXLIFE | Medical Repair Service, Inc. | 1990-10-12 | Traditional | PDF ↗ |
| K904002 | GENOX MODEL CT-1 OXYGEN/NITROGEN GENER-DISTR SYST | Pacific Consolidated Industries | 1990-09-05 | Traditional | PDF ↗ |
| K903411 | FIELD MEDICAL OXYGEN GEN/DIST SYS-BATTLEFIELD PURP | Guild Assoc., Inc. | 1990-08-31 | Traditional | PDF ↗ |
| K902890 | ASPEN 3 OXYGEN CONCENTRATOR | Mountain Medical Equipment, Inc. | 1990-07-19 | Traditional | PDF ↗ |
| K896457 | DEVILBISS MODEL PV02 SERIES | Devilbiss Health Care, Inc. | 1990-02-01 | Traditional | PDF ↗ |
| K895177 | PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR | Puritan Bennett Corp. | 1989-11-21 | Traditional | PDF ↗ |
| K895141 | MODEL 590 OXYGEN CONCENTRATOR | Puritan Bennett Corp. | 1989-10-31 | Traditional | PDF ↗ |
| K894384 | K.E.E. OXYGEN CONCENTRATOR | Kee Medical Services, Inc. | 1989-10-27 | Traditional | PDF ↗ |
| K891488 | MOBILAIRE V OXYGEN CONCENTRATOR | Invacare Corp. | 1989-05-25 | Traditional | PDF ↗ |
| K884563 | OXYGEN CONCENTRATOR W/CONCENTRATION 3LPM 93% +/-3% | Ivex Medical, Inc. | 1989-04-26 | Traditional | PDF ↗ |
| K884018 | LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT | Lamelli Pulmonary Research Center | 1989-02-27 | Traditional | PDF ↗ |
| K890150 | H-3000 OXYGEN CONCENTRATOR | Healthdyne, Inc. | 1989-01-31 | Traditional | PDF ↗ |
| K884581 | RELIANT OXYGEN CONCENTRATOR | Airsep Corp. | 1989-01-11 | Traditional | PDF ↗ |
| K883837 | MIKADO AC 405 | Ivex Medical, Inc. | 1988-12-12 | Traditional | PDF ↗ |
| K884084 | PORTABLE OXYGEN GENERATOR | Mountain Medical Equipment, Inc. | 1988-11-21 | Traditional | PDF ↗ |
| K883591 | MARK-5 CONCENTRATOR | Nidek Medical Products, Inc. | 1988-11-02 | Traditional | PDF ↗ |
| K881802 | ALPINE PORTABLE OXYGEN GENERATOR | Mountain Medical Equipment, Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K880044 | OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8 | Oxygen Enrichment Company, Ltd. | 1988-03-28 | Traditional | PDF ↗ |
Product code CAW · Class II · Anesthesiology. Data: openFDA.