Product Code: CCL
FDA class 2
21 CFR 868.1720
Analyzer, Gas, Oxygen, Gaseous-Phase
Anesthesiology
The Gaseous-Phase Oxygen Analyzer is an anesthesiology device that measures the concentration of oxygen in the gas phase of a breathing circuit or inspired gas stream, used to verify that appropriate oxygen concentrations are being delivered to patients during anesthesia, ventilation, or oxygen therapy. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CCL, regulated under 21 CFR 868.1720, within the Anesthesiology medical specialty. This device is eligible for third-party review.
510(k)s
120
FEI Numbers
82
Registration Numbers
82
Unique Applicants
89
Years Active
49
Basic Information
- Product Code
- CCL
- Device Class
- FDA class 2
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 120 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250002 | Smart Check O2 (MA0236) | Apr 24, 2025 | Substantially Equivalent | Life Spark Medical, LLC |
| K221734 | Maxtec MaxO2 ME+p | Apr 01, 2023 | Substantially Equivalent | Maxtec, LLC |
| K213933 | Percent Oxygen Sensors | Aug 19, 2022 | Substantially Equivalent | CareOx, LLC |
| K213948 | OxyMinder | Mar 17, 2022 | Substantially Equivalent | Bio-Med Devices, Inc. |
| K173807 | Accu O2 Oxygen Analyzer | May 02, 2018 | Substantially Equivalent | Precision Medical Inc. |
| K153659 | MaxO2ME | Jun 10, 2016 | Substantially Equivalent | MAXTEC, LLC |
| K123195 | CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES | Feb 28, 2013 | Substantially Equivalent | GE HEALTHCARE FINLAND OY |
| K122290 | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE | Jan 23, 2013 | Substantially Equivalent | ENVITEC-WISMAR GMBH |
| K112402 | ULTRAMAXO2 OXYGEN ANALYER | Dec 14, 2011 | Substantially Equivalent | MAXTEC, LLC |
| K082655 | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 | Nov 25, 2008 | Substantially Equivalent | ENVITEC-WISMAR GMBH |
| K072469 | DIGIFLO CONCENTRATOR ANALYZER | Jan 03, 2008 | Substantially Equivalent | DIGIFLO, INC. |
| K063096 | PRECISION OXYGEN MONITOR | Feb 27, 2007 | Substantially Equivalent | PRECISION MEDICAL, INC. |
| K063488 | MAXO2 CU | Feb 22, 2007 | Substantially Equivalent | MAXTEC, INC. |
| K053407 | OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M | Apr 05, 2006 | Substantially Equivalent | ANALYTICAL INDUSTRIES, INC. |
| K051092 | DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC | May 25, 2005 | Substantially Equivalent | GE HEALTHCARE |
| K041773 | OXYGEN MEDICELS, CITICELS | Jul 15, 2004 | Substantially Equivalent | CITY TECHNOLOGY LIMITED |
| K040484 | MAXO2+, MODEL A AND AE | Jun 09, 2004 | Substantially Equivalent | MAXTEC, INC. |
| K024228 | RX300 OXYGEN ANALYZER | Jul 17, 2003 | Substantially Equivalent | TELEDYNE ANALYTICAL INSTRUMENTS |
| K024155 | MX 300 OXYGEN MONITOR | Jul 17, 2003 | Substantially Equivalent | TELEDYNE ANALYTICAL INSTRUMENTS |
| K023565 | OXICHECK | Mar 28, 2003 | Substantially Equivalent | CARADYNE, LTD. |
| K010318 | PRIMA OXYGEN MONITOR | Jul 23, 2001 | Substantially Equivalent | PENLON LTD. |
| K002382 | 'ALL 2000' % OXYGEN ANALYZER | Mar 14, 2001 | Substantially Equivalent | ANALYTICAL INDUSTRIES, INC. |
| K010382 | 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I | Mar 01, 2001 | Substantially Equivalent | SENSIDYNE, INC. |
| K002384 | M-XX OXYGEN SENSORS | Dec 15, 2000 | Substantially Equivalent | INTERNATIONAL BUSINESS STRATEGIES |
| K000700 | SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR | Aug 31, 2000 | Substantially Equivalent | SENSIDYNE, INC. |
| K001095 | OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 | Jun 30, 2000 | Substantially Equivalent | TELEDYNE ANALYTICAL INSTRUMENTS |
| K990403 | TED 200T7 OXYGEN MONITOR | Feb 03, 2000 | Substantially Equivalent | TELEDYNE ELECTRONIC TECHNOLOGIES |
| K990457 | TED 60T OXYGEN ANALYZER | Nov 09, 1999 | Substantially Equivalent | TELEDYNE ELECTRONIC TECHNOLOGIES |
| K991884 | SIEMENS FIO2 SENSOR | Nov 03, 1999 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K984295 | INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS) | Jul 09, 1999 | Substantially Equivalent | INVACARE CORP. |
| K983500 | PRO2 CHECK OXYGEN INDICATOR | Mar 17, 1999 | Substantially Equivalent | MEDICAL TECHNOLOGY SPECIALISTS, INC. |
| K982619 | HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 | Aug 12, 1998 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K971084 | MODEL 02 OXYGEN ANALYZER | Jul 21, 1998 | Substantially Equivalent | OXIGRAF, INC. |
| K973545 | VACU*MED GOLD EDITION OXYGEN GAS ANALYZER | May 26, 1998 | Substantially Equivalent | VACUMED, DIV. OF VACUMETRICS, INC. |
| K972992 | CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS | Mar 30, 1998 | Substantially Equivalent | CERAMATEC, INC. |
| K973282 | HANDI OXYGEN ANALYZER | Mar 04, 1998 | Substantially Equivalent | CERAMATEC, INC. |
| K963177 | TED 191 | Nov 13, 1997 | Substantially Equivalent | TELEDYNE BROWN ENGINEERING |
| K963415 | VENTREX OXYGEN SENSOR | Nov 25, 1996 | Substantially Equivalent | VENTREX, LLC. |
| K943824 | GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION | Nov 01, 1996 | Substantially Equivalent | AMETEK, INC. |
| K961644 | MINIOX 3000 OXYGEN MONITOR | Jul 25, 1996 | Substantially Equivalent | MINE SAFETY APPLIANCES, CO. |
| K951038 | OXYCHECK OXYGEN MONITOR | Jan 11, 1996 | Substantially Equivalent | OXYCHECK, INC. |
| K952736 | PERCENT OXYGEN SENSOR | Oct 18, 1995 | Substantially Equivalent | ANALYTICAL INDUSTRIES, INC. |
| K953351 | SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS | Oct 16, 1995 | Substantially Equivalent | SEATRONICS CO. |
| K941793 | OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) | Jun 21, 1995 | Substantially Equivalent | MOUNTAIN MEDICAL EQUIPMENT, INC. |
| K944120 | FI02 SENSING MODULE | May 10, 1995 | Substantially Equivalent | CORE-M, L.P. |
| K942593 | OXYCHEK OXYGEN ANALYZER | May 03, 1995 | Substantially Equivalent | NIDEK MEDICAL PRODUCTS, INC. |
| K944654 | OXYGEN CONCENTRATION INDICATOR | Nov 08, 1994 | Substantially Equivalent | AEQUITRON MEDICAL, INC. |
| K935364 | MINIOX 1000 OXYGEN CONCENTRATION INDICATOR | Jun 14, 1994 | Substantially Equivalent | MINE SAFETY APPLIANCES, CO. |
| K922438 | PRO2 OXYGEN ANALYZER | Mar 05, 1993 | Substantially Equivalent | MARTECH MEDICAL PRODUCTS, INC. |
| K922738 | VTI OXYGEN ANALYZER | Jan 27, 1993 | Substantially Equivalent | VASCULAR TECHNOLOGY INCORPORATED |
| K920338 | COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR | Aug 27, 1992 | Substantially Equivalent | PURITAN BENNETT CORP. |
| K913392 | OXYGEN SENSING DEVICE, MODIFICATION | Jul 17, 1992 | Substantially Equivalent | DEVILBISS HEALTH CARE, INC. |
| K910381 | BIOCHEM TEMPERATURE/ FIO2 MODULE | Aug 22, 1991 | Substantially Equivalent | BIOCHEM INTERNATIONAL, INC. |
| K911344 | CERION HAND HELD OXYGEN ANALYZER | Jun 18, 1991 | Substantially Equivalent | CERAMATEC, INC. |
| K896359 | AG-820PA FI02 MODULE | Mar 09, 1990 | Substantially Equivalent | NIHON KOHDEN AMERICA, INC. |
| K896427 | SPACELABS' MODEL 90514, MULTIGAS ANALYZER | Jan 24, 1990 | Substantially Equivalent | SPACELABS, INC. |
| K890058 | VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM | Nov 21, 1989 | Substantially Equivalent | VASCULAR TECHNOLOGY INCORPORATED |
| K894918 | HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. | Oct 31, 1989 | Substantially Equivalent | MENNEN MEDICAL, INC. |
| K891674 | NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 | Aug 31, 1989 | Substantially Equivalent | PREEMICARE CORP. |
| K890144 | OXITRON OXYGEN SENSOR | May 25, 1989 | Substantially Equivalent | OXITRON MEDICAL PRODUCTS |
| K890958 | OXITRON OXYGEN ANALYZER | May 22, 1989 | Substantially Equivalent | OXITRON MEDICAL PRODUCTS |
| K882352 | MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT. | Nov 02, 1988 | Substantially Equivalent | CLINICAL INFORMATION SYSTEMS, INC. |
| K880378 | LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 | Sep 30, 1988 | Substantially Equivalent | LIFECARE SERVICES, INC. |
| K883254 | MULTINEX MONITOR (MODIFICATION) | Sep 12, 1988 | Substantially Equivalent | DATASCOPE CORP. |
| K882743 | OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR) | Aug 24, 1988 | Substantially Equivalent | OHMEDA MEDICAL |
| K881663 | OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES | Aug 19, 1988 | Substantially Equivalent | SALTER LABS |
| K881473 | SL01 OXYGEN ANALYZER | Jun 16, 1988 | Substantially Equivalent | SALTER LABS |
| K881472 | SL02 OXYGEN ANALYZER | Jun 16, 1988 | Substantially Equivalent | SALTER LABS |
| K875183 | LC OXYGEN ANALYZER | Mar 29, 1988 | Substantially Equivalent | AMETEK/THERMOX INSTRUMENTS DIVISION |
| K880448 | CERION OXY THRESHOLD ALARM | Mar 21, 1988 | Substantially Equivalent | CERAMATEC, INC. |
| K873068 | OXYGEN ANALYZER MODEL 800 SERIES | Oct 20, 1987 | Substantially Equivalent | SALTER INSTRUMENTATION, INC. |
| K872001 | MODEL TPC-1A OXYGEN ANALYZER | Jun 15, 1987 | Substantially Equivalent | MEDICAL, INC. |
| K871337 | M-2 OXYGEN/TEMPERATURE MONITOR | Jun 05, 1987 | Substantially Equivalent | BIO-MED DEVICES, INC. |
| K863158 | MODEL T-1 OXYGEN ANALYZER | Nov 13, 1986 | Substantially Equivalent | CHRYSALIS SYSTEMS, INC. |
| K863806 | MODEL A-1 OXYGEN ANALYZER | Oct 15, 1986 | Substantially Equivalent | MEDICAL, INC. |
| K862113 | NO. 100352 GALVANIC OXYGEN SENSOR | Jun 19, 1986 | Substantially Equivalent | VASCULAR TECHNOLOGY INCORPORATED |
| K861625 | SERVO GAS MONITOR 120 | May 02, 1986 | Substantially Equivalent | SIEMENS ELEMA AB |
| K854799 | EMERSON MODEL 3MV-OAA ALARM MODULE | Dec 11, 1985 | Substantially Equivalent | J. H. EMERSON CO. |
| K854599 | VICKERS MEDICAL MODEL 273 OXYGEN MONITOR | Nov 27, 1985 | Substantially Equivalent | VICKERS LTD. |
| K852823 | DMA OXYGEN MONITOR | Oct 29, 1985 | Substantially Equivalent | FERGUSON MEDICAL |
| K853082 | OHMEDA 5120 OXYGEN MONITOR | Jul 31, 1985 | Substantially Equivalent | OHMEDA MEDICAL |
| K852275 | VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR | Jun 20, 1985 | Substantially Equivalent | VASCULAR TECHNOLOGY INCORPORATED |
| K843847 | O2 TEST | Oct 12, 1984 | Substantially Equivalent | ERICH JAEGER, INC. |
| K840645 | ENGSTROM ELIZA DUO CO2 & O2 ANALYZ | Apr 05, 1984 | Substantially Equivalent | GAMBRO, INC. |
| K840565 | MONITOR 5590- ANALYZER 5595EC | Apr 02, 1984 | Substantially Equivalent | HUDSON OXYGEN THERAPY SALES CO. |
| K840392 | NOVOX OXYGEN ANALYZER 400 | Feb 27, 1984 | Substantially Equivalent | NOVAMETRIX MEDICAL SYSTEMS, INC. |
| K840361 | OXYGEN ANALYZER 200 | Feb 17, 1984 | Substantially Equivalent | SALTER LABS |
| K833496 | OXYGEN MONITOR/CONTROLLER | Dec 16, 1983 | Substantially Equivalent | OXEQUIP HEALTH IND. |
| K833995 | MINI OX II | Dec 12, 1983 | Substantially Equivalent | CATALYST RESEARCH CORP. |
| K831522 | BIO-TEK PERCENT OXYGEN MONITOR 74222 | Sep 12, 1983 | Substantially Equivalent | BIO-TEK INSTRUMENTS, INC. |
| K831238 | OXYMED | May 09, 1983 | Substantially Equivalent | DRAEGER MEDICAL, INC. |
| K830446 | OXYGEN MONITOR OHIO 5100 | Mar 24, 1983 | Substantially Equivalent | AIRCO/OHIO MEDICAL PRODUCTS |
| K830124 | OPTION A02 MODEL 15202A | Feb 09, 1983 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K823449 | RESPIRATORY GAS ANALYZER | Jan 05, 1983 | Substantially Equivalent | THORATEC LABORATORIES CORP. |
| K823374 | OXYGEN MONITOR IL 408 | Dec 09, 1982 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K823232 | YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP | Dec 07, 1982 | Substantially Equivalent | YELLOW SPRINGS INSTRUMENT CO., INC. |
| K823231 | YSI #2600 MULTI-CHANNEL DUAL-DISPLAY | Dec 07, 1982 | Substantially Equivalent | YELLOW SPRINGS INSTRUMENT CO., INC. |
| K822608 | MK 808 SERIES NASAL OXYGEN SAMPLER | Oct 04, 1982 | Substantially Equivalent | INSTRUMENTATION INDUSTRIES, INC. |
| K821392 | MODEL TPC-1 OXYGEN ANALYZER | Jul 08, 1982 | Substantially Equivalent | MARATHON |
| K813198 | RESPIRATOR MONITOR | Dec 08, 1981 | Substantially Equivalent | FLORIDA MEDICAL EQUIPMENT REPAIR, INC. |
| K812855 | VENTRONICS #5595 ECII OXYGEN ANALYZER | Nov 06, 1981 | Substantially Equivalent | VENTRONICS, DIV OF HUDSON OXYGEN THERAPY SALES CO. |
| K812854 | VENTRONICS #5590 ECII OXYGEN MONITOR | Nov 06, 1981 | Substantially Equivalent | VENTRONICS, DIV OF HUDSON OXYGEN THERAPY SALES CO. |
| K812587 | MONO 2 OXYGEN MONITOR | Oct 06, 1981 | Substantially Equivalent | KANTRON CARDIOVASCULAR, INC. |
| K812040 | OXYGEN MONITOR 140/141 | Sep 21, 1981 | Substantially Equivalent | MEDIX MEDICAL ELECTRONICS (U.S.A.), INC. |
| K811702 | MODEL 381 HOME OXYGEN SENTRY | Jul 16, 1981 | Substantially Equivalent | STANLEY AVIATION CORP. |
| K810571 | NEOCARE OXYGEN MONITOR | Mar 11, 1981 | Substantially Equivalent | VICKERS AMERICA MEDICAL CORP. |
| K802762 | NORMOCAP CR-102, RECORDER UNIT | Nov 26, 1980 | Substantially Equivalent | INSTRUMENTARIUM-DATEX |
| K801607 | MOM 2 | Aug 07, 1980 | Substantially Equivalent | NEOTRONICS, INC. |
| K801083 | NORMCAP CD-102, CARBON DIOXIDE ANALYZER | May 28, 1980 | Substantially Equivalent | INSTRUMENTARIUM-DATEX |
| K792356 | OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR | Dec 04, 1979 | Substantially Equivalent | OXEQUIP HEALTH IND. |
| K791199 | ANESTHESIA OXYGEN ANALYZER MODEL 101 | Aug 03, 1979 | Substantially Equivalent | RULE MEDICAL INSTRUMENTS, INC. |
| K790785 | MODEL M25RL, (CRC) OXYGEN ANALYZER | Apr 27, 1979 | Substantially Equivalent | CATALYST RESEARCH CORP. |
| K790784 | MODEL M25R, OXYGEN ANALYZER | Apr 27, 1979 | Substantially Equivalent | CATALYST RESEARCH CORP. |
| K782062 | ANALYZER, OXYGEN MODEL M25RA & M25RAD | Feb 15, 1979 | Substantially Equivalent | CATALYST RESEARCH CORP. |
| K782114 | MONITOR, OXYCHEK OXYGEN | Jan 18, 1979 | Substantially Equivalent | CRITIKON COMPANY,LLC |
| K781209 | MONITOR, OXYGEN, MODEL 3000A | Aug 14, 1978 | Substantially Equivalent | OXYAIR ENGINEERING, INC. |
| K780448 | TRANSPORTABLE OXYGEN PURITY ANALYZER | Apr 19, 1978 | Substantially Equivalent | TAYLOR INSTRUMENT ANALYTICS CO. |
| K771028 | ANALYZER, OXYGEN, MODEL OM-92 | Jul 05, 1977 | Substantially Equivalent | CAVITRON CORP. |
| K770207 | MONITOR, OXYGEN, MODEL 78216C | Feb 17, 1977 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K760338 | MONITOR, RESP. OXYGEN (TOP) | Aug 11, 1976 | Substantially Equivalent | SHERWOOD MEDICAL INDUSTRIES |
FEI Numbers
This FDA classification entry is associated with 82 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 82 registration numbers. Click on an entry to view related FDA registrations.