Analyzer, Gas, Oxygen, Gaseous-Phase
FDA product code CCL · Class II (moderate risk) · 21 CFR 868.1720 · Anesthesiology
122510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Salter Labs 5
- Maxtec, LLC 5
- Vascular Technology Incorporated 4
- Ceramatec, Inc. 4
- Catalyst Research Corp. 4
- Teledyne Analytical Instruments 3
- Analytical Industries, Inc. 3
- Hewlett-Packard Co. 3
- Minesafety Appliances Co. 2
- Medical, Inc. 2
- Oxequip Health Ind. 2
- Instrumentarium-Datex 2
- Sensidyne, Inc. 2
- Precision Medical, Inc. 2
- Teledyne Electronic Technologies 2
- Bio-Med Devices, Inc. 2
- Ventronics, Div of Hudson Oxygen Therapy Sales Co. 2
- Ohmeda Medical 2
- Oxitron Medical Products 2
- Yellow Springs Instrument Co., Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)CCL · Traditional | Salter Labs | 07/30/2026SE |
| K251245 | OxyMinder Pro (10310)CCL · Traditional | Bio-Med Device, Inc. | 08/11/2025SE |
| K250002 | Smart Check O2 (MA0236)CCL · Traditional | Life Spark Medical, LLC | 04/24/2025SE |
| K221734 | Maxtec MaxO2 ME+pCCL · Traditional | Maxtec, LLC | 04/01/2023SE |
| K213933 | Percent Oxygen SensorsCCL · Traditional | Careox, LLC | 08/19/2022SE |
| K213948 | OxyMinderCCL · Traditional | Bio-Med Devices, Inc. | 03/17/2022SE |
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | Precision Medical, Inc. | 05/02/2018SE |
| K153659 | MaxO2MECCL · Traditional | Maxtec, LLC | 06/10/2016SE |
| K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesCCL · Traditional | GE Healthcare Finland Oy | 02/28/2013SE |
| K122290 | Envitec Mysign O Oxygen Measuring DeviceCCL · Traditional | Envitec-Wismar GmbH | 01/23/2013SE |
| K112402 | ULTRAMAXO2 Oxygen AnalyerCCL · Abbreviated | Maxtec, LLC | 12/14/2011SE |
| K082655 | Envitec Medical Oxygen Senors, Models OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106CCL · Traditional | Envitec-Wismar GmbH | 11/25/2008SE |
| K072469 | Digiflo Concentrator AnalyzerCCL · Traditional | Digiflo, Inc. | 01/03/2008SE |
| K063096 | Precision Oxygen MonitorCCL · Abbreviated | Precision Medical, Inc. | 02/27/2007SE |
| K063488 | MAXO2 CuCCL · Traditional | Maxtec, Inc. | 02/22/2007SE |
| K053407 | Oxygen Analyzer, Models Aii 20000A, Aii 2000HC, Aii 2000MCCL · Traditional | Analytical Industries, Inc. | 04/05/2006SE |
| K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov…CCL · Special | GE Healthcare | 05/25/2005SE |
| K041773 | Oxygen Medicels, CiticelsCCL · Traditional | City Technology Limited | 07/15/2004SE |
| K040484 | MAXO2+, Model a and AeCCL · Traditional | Maxtec, Inc. | 06/09/2004SE |
| K024228 | RX300 Oxygen AnalyzerCCL · Traditional | Teledyne Analytical Instruments | 07/17/2003SE |
| K024155 | MX 300 Oxygen MonitorCCL · Traditional | Teledyne Analytical Instruments | 07/17/2003SE |
| K023565 | OxicheckCCL · Abbreviated | Caradyne, Ltd. | 03/28/2003SE |
| K010318 | Prima Oxygen MonitorCCL · Traditional | Penlon , Ltd. | 07/23/2001SE |
| K002382 | 'All 2000' % Oxygen AnalyzerCCL · Traditional | Analytical Industries, Inc. | 03/14/2001SE |
| K010382 | 100 Series Oxygen Analyzer, Models 1000-E and 1000-ICCL · Special | Sensidyne, Inc. | 03/01/2001SE |
| K002384 | M-Xx Oxygen SensorsCCL · Abbreviated | International Business Strategies | 12/15/2000SE |
| K000700 | Sensidyne Oxygen Analyzer & Sensidyne Oxygen MonitorCCL · Traditional | Sensidyne, Inc. | 08/31/2000SE |
| K001095 | Oxygen Sensors, Models Cir, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1…CCL · Traditional | Teledyne Analytical Instruments | 06/30/2000SE |
| K990403 | Ted 200T7 Oxygen MonitorCCL · Traditional | Teledyne Electronic Technologies | 02/03/2000SE |
| K990457 | Ted 60T Oxygen AnalyzerCCL · Traditional | Teledyne Electronic Technologies | 11/09/1999SE |
| K991884 | Siemens FIO2 SensorCCL · Traditional | Siemens Medical Solutions USA, Inc. | 11/03/1999SE |
| K984295 | Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus)CCL · Traditional | Invacare Corp. | 07/09/1999SE |
| K983500 | PRO2 Check Oxygen IndicatorCCL · Traditional | Medical Technology Specialists, Inc. | 03/17/1999SE |
| K982619 | HP Anesthesia Gas Monitor (Watertrap), Model A02CCL · Special | Hewlett-Packard Co. | 08/12/1998SE |
| K971084 | Model 02 Oxygen AnalyzerCCL · Traditional | Oxigraf, Inc. | 07/21/1998SE |
| K973545 | Vacu*Med Gold Edition Oxygen Gas AnalyzerCCL · Traditional | Vacumed, Div. of Vacumetrics, Inc. | 05/26/1998SE |
| K972992 | Ceramatec Maxcell and Cag Galvanic Oxygen SensorsCCL · Traditional | Ceramatec, Inc. | 03/30/1998SE |
| K973282 | Handi Oxygen AnalyzerCCL · Traditional | Ceramatec, Inc. | 03/04/1998SE |
| K963177 | Ted 191CCL · Traditional | Teledyne Brown Engineering | 11/13/1997SE |
| K963415 | Ventrex Oxygen SensorCCL · Traditional | Ventrex, LLC | 11/25/1996SE |
| K943824 | Gaseous Oxygen Analyzer (Model S-3A) ModificationCCL · Traditional | Ametek, Inc. | 11/01/1996SE |
| K961644 | Miniox 3000 Oxygen MonitorCCL · Traditional | Minesafety Appliances Co. | 07/25/1996SE |
| K951038 | Oxycheck Oxygen MonitorCCL · Traditional | Oxycheck, Inc. | 01/11/1996SE |
| K952736 | Percent Oxygen SensorCCL · Traditional | Analytical Industries, Inc. | 10/18/1995SE |
| K953351 | Seatronics Family of Galvanic Oxygen SensorsCCL · Traditional | Seatronics Co. | 10/16/1995SE |
| K941793 | Oxygen Concentration Status Indicator (O.C.S.I.)CCL · Traditional | Mountain Medical Equipment, Inc. | 06/21/1995SE |
| K944120 | FI02 Sensing ModuleCCL · Traditional | Core-M, L.P. | 05/10/1995SE |
| K942593 | Oxychek Oxygen AnalyzerCCL · Traditional | Nidek Medical Products, Inc. | 05/03/1995SE |
| K944654 | Oxygen Concentration IndicatorCCL · Traditional | Aequitron Medical, Inc. | 11/08/1994SE |
| K935364 | Miniox 1000 Oxygen Concentration IndicatorCCL · Traditional | Minesafety Appliances Co. | 06/14/1994SE |
| K922438 | PRO2 Oxygen AnalyzerCCL · Traditional | Martech Medical Products, Inc. | 03/05/1993SE |
| K922738 | Vti Oxygen AnalyzerCCL · Traditional | Vascular Technology Incorporated | 01/27/1993SE |
| K920338 | Companion Retrofit Oxygen Concentration IndicatorCCL · Traditional | Puritan Bennett Corp. | 08/27/1992SE |
| K913392 | Oxygen Sensing Device, ModificationCCL · Traditional | Devilbiss Health Care, Inc. | 07/17/1992SE |
| K910381 | Biochem Temperature/ FIO2 ModuleCCL · Traditional | Biochem International, Inc. | 08/22/1991SE |
| K911344 | Cerion Hand Held Oxygen AnalyzerCCL · Traditional | Ceramatec, Inc. | 06/18/1991SE |
| K896359 | AG-820PA FI02 ModuleCCL · Traditional | Nihon Kohden America, Inc. | 03/09/1990SE |
| K896427 | Spacelabs' Model 90514, Multigas AnalyzerCCL · Traditional | Spacelabs, Inc. | 01/24/1990SE |
| K890058 | Vascular Technology Uniox Oxygen AlarmCCL · Traditional | Vascular Technology Incorporated | 11/21/1989SE |
| K894918 | Horizon 2000 Fraction of Inspired Oxygen Mon. Cap.CCL · Traditional | Mennen Medical, Inc. | 10/31/1989SE |
| K891674 | Neonatal Environmental Monitor, Model 275CCL · Traditional | Preemicare Corp. | 08/31/1989SE |
| K890144 | Oxitron Oxygen SensorCCL · Traditional | Oxitron Medical Products | 05/25/1989SE |
| K890958 | Oxitron Oxygen AnalyzerCCL · Traditional | Oxitron Medical Products | 05/22/1989SE |
| K882352 | Model IDS640 Patient Data Display & Storage Monit.CCL · Traditional | Clinical Information Systems, Inc. | 11/02/1988SE |
| K880378 | Lota, Lifecare Oxygen/Temperature Analyzer 36-001CCL · Traditional | Lifecare Services, Inc. | 09/30/1988SE |
| K883254 | Multinex Monitor (Modification)CCL · Traditional | Datascope Corp. | 09/12/1988SE |
| K882743 | Ohmeda 5250 RGM (Respiratory Gas Monitor)CCL · Traditional | Ohmeda Medical | 08/24/1988SE |
| K881663 | Oxygen/Temperature Analyzer Model 300 SeriesCCL · Traditional | Salter Labs | 08/19/1988SE |
| K881473 | SL01 Oxygen AnalyzerCCL · Traditional | Salter Labs | 06/16/1988SE |
| K881472 | SL02 Oxygen AnalyzerCCL · Traditional | Salter Labs | 06/16/1988SE |
| K875183 | LC Oxygen AnalyzerCCL · Traditional | Ametek/Thermox Instruments Division | 03/29/1988SE |
| K880448 | Cerion Oxy Threshold AlarmCCL · Traditional | Ceramatec, Inc. | 03/21/1988SE |
| K873068 | Oxygen Analyzer Model 800 SeriesCCL · Traditional | Salter Instrumentation, Inc. | 10/20/1987SE |
| K872001 | Model TPC-1A Oxygen AnalyzerCCL · Traditional | Medical, Inc. | 06/15/1987SE |
| K871337 | M-2 Oxygen/Temperature MonitorCCL · Traditional | Bio-Med Devices, Inc. | 06/05/1987SE |
| K863158 | Model T-1 Oxygen AnalyzerCCL · Traditional | Chrysalis Systems, Inc. | 11/13/1986SE |
| K863806 | Model A-1 Oxygen AnalyzerCCL · Traditional | Medical, Inc. | 10/15/1986SE |
| K862113 | No. 100352 Galvanic Oxygen SensorCCL · Traditional | Vascular Technology Incorporated | 06/19/1986SE |
| K861625 | Servo Gas Monitor 120CCL · Traditional | Siemens Elema AB | 05/02/1986SE |
| K854799 | Emerson Model 3MV-OAA Alarm ModuleCCL · Traditional | J. H. Emerson Co. | 12/11/1985SE |
| K854599 | Vickers Medical Model 273 Oxygen MonitorCCL · Traditional | Vickers , Ltd. | 11/27/1985SE |
| K852823 | Dma Oxygen MonitorCCL · Traditional | Ferguson Medical | 10/29/1985SE |
| K853082 | Ohmeda 5120 Oxygen MonitorCCL · Traditional | Ohmeda Medical | 07/31/1985SE |
| K852275 | Vascular Tech # 100123 Polarographic Oxgyen SensorCCL · Traditional | Vascular Technology Incorporated | 06/20/1985SE |
| K843847 | O2 TestCCL · Traditional | Erich Jaeger, Inc. | 10/12/1984SE |
| K840645 | Engstrom Eliza Duo CO2 & O2 AnalyzCCL · Traditional | Gambro, Inc. | 04/05/1984SE |
| K840565 | Monitor 5590- Analyzer 5595ECCCL · Traditional | Hudson Oxygen Therapy Sales Co. | 04/02/1984SE |
| K840392 | Novox Oxygen Analyzer 400CCL · Traditional | Novametrix Medical Systems, Inc. | 02/27/1984SE |
| K840361 | Oxygen Analyzer 200CCL · Traditional | Salter Labs | 02/17/1984SE |
| K833496 | Oxygen Monitor/ControllerCCL · Traditional | Oxequip Health Ind. | 12/16/1983SE |
| K833995 | Mini Ox IICCL · Traditional | Catalyst Research Corp. | 12/12/1983SE |
| K831522 | Bio-Tek Percent Oxygen Monitor 74222CCL · Traditional | Bio-Tek Instruments, Inc. | 09/12/1983SE |
| K831238 | OxymedCCL · Traditional | Draeger Medical, Inc. | 05/09/1983SE |
| K830446 | Oxygen Monitor Ohio 5100CCL · Traditional | Airco/Ohio Medical Products | 03/24/1983SE |
| K830124 | Option A02 Model 15202ACCL · Traditional | Hewlett-Packard Co. | 02/09/1983SE |
| K823449 | Respiratory Gas AnalyzerCCL · Traditional | Thoratec Laboratories Corp. | 01/05/1983SE |
| K823374 | Oxygen Monitor Il 408CCL · Traditional | Instrumentation Laboratory CO | 12/09/1982SE |
| K823232 | Ysi #2650 Single-Display Oxygen & TempCCL · Traditional | Yellow Springs Instrument Co., Inc. | 12/07/1982SE |
| K823231 | Ysi #2600 Multi-Channel Dual-DisplayCCL · Traditional | Yellow Springs Instrument Co., Inc. | 12/07/1982SE |
| K822608 | MK 808 Series Nasal Oxygen SamplerCCL · Traditional | Instrumentation Industries, Inc. | 10/04/1982SE |
| K821392 | Model TPC-1 Oxygen AnalyzerCCL · Traditional | Marathon | 07/08/1982SE |
| K813198 | Respirator MonitorCCL · Traditional | Florida Medical Equipment Repair, Inc. | 12/08/1981SE |
| K812855 | Ventronics #5595 Ecii Oxygen AnalyzerCCL · Traditional | Ventronics, Div of Hudson Oxygen Therapy Sales Co. | 11/06/1981SE |
| K812854 | Ventronics #5590 Ecii Oxygen MonitorCCL · Traditional | Ventronics, Div of Hudson Oxygen Therapy Sales Co. | 11/06/1981SE |
| K812587 | Mono 2 Oxygen MonitorCCL · Traditional | Kantron Cardiovascular, Inc. | 10/06/1981SE |
| K812040 | Oxygen Monitor 140/141CCL · Traditional | Medix Medical Electronics (U.S.A.), Inc. | 09/21/1981SE |
| K811702 | Model 381 Home Oxygen SentryCCL · Traditional | Stanley Aviation Corp. | 07/16/1981SE |
| K810571 | Neocare Oxygen MonitorCCL · Traditional | Vickers America Medical Corp. | 03/11/1981SE |
| K802762 | Normocap CR-102, Recorder UnitCCL · Traditional | Instrumentarium-Datex | 11/26/1980SE |
| K801607 | Mom 2CCL · Traditional | Neotronics, Inc. | 08/07/1980SE |
| K801083 | Normcap CD-102, Carbon Dioxide AnalyzerCCL · Traditional | Instrumentarium-Datex | 05/28/1980SE |
| K792356 | Oxequip Model 34 Med*Star Oxygen MonitorCCL · Traditional | Oxequip Health Ind. | 12/04/1979SE |
| K791199 | Anesthesia Oxygen Analyzer Model 101CCL · Traditional | Rule Medical Instruments, Inc. | 08/03/1979SE |
| K790785 | Model M25RL, (CRC) Oxygen AnalyzerCCL · Traditional | Catalyst Research Corp. | 04/27/1979SE |
| K790784 | Model M25R, Oxygen AnalyzerCCL · Traditional | Catalyst Research Corp. | 04/27/1979SE |
| K782062 | Analyzer, Oxygen Model M25RA & M25RADCCL · Traditional | Catalyst Research Corp. | 02/15/1979SE |
| K782114 | Monitor, Oxychek OxygenCCL · Traditional | Critikon Company, LLC | 01/18/1979SE |
| K781209 | Monitor, Oxygen, Model 3000ACCL · Traditional | Oxyair Engineering, Inc. | 08/14/1978SE |
| K780448 | Transportable Oxygen Purity AnalyzerCCL · Traditional | Taylor Instrument Analytics Co. | 04/19/1978SE |
| K771028 | Analyzer, Oxygen, Model OM-92CCL · Traditional | Cavitron Corp. | 07/05/1977SE |
| K770207 | Monitor, Oxygen, Model 78216CCCL · Traditional | Hewlett-Packard Co. | 02/17/1977SE |
| K760338 | Monitor, Resp. Oxygen (Top)CCL · Traditional | Sherwood Medical Industries | 08/11/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1680-2015 Class II | D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact…A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend /… | GE Healthcare | 04/24/2015Terminated |
| Z-2617-2014 Class II | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the…GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor… | GE Healthcare, LLC | 08/08/2014Terminated |
| Z-1808-2014 Class II | GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX.…Potential loss of airway gas measurement in the Compact Airway Gas Modules. Loosening of the gas sampling… | GE Healthcare, LLC | 05/23/2014Terminated |
| Z-0585-2010 | Oxygen Sensor #5804, Distributed by: Teleflex Medical, Research Triangle Park, NC 27709Sensor causes the oxygen monitor to display prematurely a Low Sensor warning which indicates an early… | Teleflex Medical | 11/25/2009Terminated |