FDA Product Code
FDA Product Code CCL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.1720
510(k) Clearances — 122 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | 2026-07-30 | Traditional | PDF ↗ |
| K251245 | OxyMinder Pro (10310) | Bio-Med Device, Inc. | 2025-08-11 | Traditional | PDF ↗ |
| K250002 | Smart Check O2 (MA0236) | Life Spark Medical, LLC | 2025-04-24 | Traditional | PDF ↗ |
| K221734 | Maxtec MaxO2 ME+p | Maxtec, LLC | 2023-04-01 | Traditional | PDF ↗ |
| K213933 | Percent Oxygen Sensors | Careox, LLC | 2022-08-19 | Traditional | PDF ↗ |
| K213948 | OxyMinder | Bio-Med Devices, Inc. | 2022-03-17 | Traditional | PDF ↗ |
| K173807 | Accu O2 Oxygen Analyzer | Precision Medical, Inc. | 2018-05-02 | Abbreviated | PDF ↗ |
| K153659 | MaxO2ME | Maxtec, LLC | 2016-06-10 | Traditional | PDF ↗ |
| K123195 | CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES | GE Healthcare Finland Oy | 2013-02-28 | Traditional | PDF ↗ |
| K122290 | ENVITEC MYSIGN O OXYGEN MEASURING DEVICE | Envitec-Wismar GmbH | 2013-01-23 | Traditional | PDF ↗ |
| K112402 | ULTRAMAXO2 OXYGEN ANALYER | Maxtec, LLC | 2011-12-14 | Abbreviated | PDF ↗ |
| K082655 | ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 | Envitec-Wismar GmbH | 2008-11-25 | Traditional | PDF ↗ |
| K072469 | DIGIFLO CONCENTRATOR ANALYZER | Digiflo, Inc. | 2008-01-03 | Traditional | PDF ↗ |
| K063096 | PRECISION OXYGEN MONITOR | Precision Medical, Inc. | 2007-02-27 | Abbreviated | PDF ↗ |
| K063488 | MAXO2 CU | Maxtec, Inc. | 2007-02-22 | Traditional | PDF ↗ |
| K053407 | OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M | Analytical Industries, Inc. | 2006-04-05 | Traditional | PDF ↗ |
| 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 | GE Healthcare | 2005-05-25 | Special | PDF ↗ |
| K041773 | OXYGEN MEDICELS, CITICELS | City Technology Limited | 2004-07-15 | Traditional | PDF ↗ |
| K040484 | MAXO2+, MODEL A AND AE | Maxtec, Inc. | 2004-06-09 | Traditional | PDF ↗ |
| K024228 | RX300 OXYGEN ANALYZER | Teledyne Analytical Instruments | 2003-07-17 | Traditional | PDF ↗ |
| K024155 | MX 300 OXYGEN MONITOR | Teledyne Analytical Instruments | 2003-07-17 | Traditional | PDF ↗ |
| K023565 | OXICHECK | Caradyne, Ltd. | 2003-03-28 | Abbreviated | PDF ↗ |
| K010318 | PRIMA OXYGEN MONITOR | Penlon , Ltd. | 2001-07-23 | Traditional | PDF ↗ |
| K002382 | 'ALL 2000' % OXYGEN ANALYZER | Analytical Industries, Inc. | 2001-03-14 | Traditional | PDF ↗ |
| K010382 | 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I | Sensidyne, Inc. | 2001-03-01 | Special | PDF ↗ |
| K002384 | M-XX OXYGEN SENSORS | International Business Strategies | 2000-12-15 | Abbreviated | PDF ↗ |
| K000700 | SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR | Sensidyne, Inc. | 2000-08-31 | Traditional | PDF ↗ |
| K001095 | OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 | Teledyne Analytical Instruments | 2000-06-30 | Traditional | PDF ↗ |
| K990403 | TED 200T7 OXYGEN MONITOR | Teledyne Electronic Technologies | 2000-02-03 | Traditional | PDF ↗ |
| K990457 | TED 60T OXYGEN ANALYZER | Teledyne Electronic Technologies | 1999-11-09 | Traditional | PDF ↗ |
| K991884 | SIEMENS FIO2 SENSOR | Siemens Medical Solutions USA, Inc. | 1999-11-03 | Traditional | PDF ↗ |
| K984295 | INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS) | Invacare Corp. | 1999-07-09 | Traditional | PDF ↗ |
| K983500 | PRO2 CHECK OXYGEN INDICATOR | Medical Technology Specialists, Inc. | 1999-03-17 | Traditional | PDF ↗ |
| K982619 | HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 | Hewlett-Packard Co. | 1998-08-12 | Special | PDF ↗ |
| K971084 | MODEL 02 OXYGEN ANALYZER | Oxigraf, Inc. | 1998-07-21 | Traditional | PDF ↗ |
| K973545 | VACU*MED GOLD EDITION OXYGEN GAS ANALYZER | Vacumed, Div. of Vacumetrics, Inc. | 1998-05-26 | Traditional | PDF ↗ |
| K972992 | CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS | Ceramatec, Inc. | 1998-03-30 | Traditional | PDF ↗ |
| K973282 | HANDI OXYGEN ANALYZER | Ceramatec, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K963177 | TED 191 | Teledyne Brown Engineering | 1997-11-13 | Traditional | PDF ↗ |
| K963415 | VENTREX OXYGEN SENSOR | Ventrex, LLC | 1996-11-25 | Traditional | PDF ↗ |
| K943824 | GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION | Ametek, Inc. | 1996-11-01 | Traditional | PDF ↗ |
| K961644 | MINIOX 3000 OXYGEN MONITOR | Minesafety Appliances Co. | 1996-07-25 | Traditional | PDF ↗ |
| K951038 | OXYCHECK OXYGEN MONITOR | Oxycheck, Inc. | 1996-01-11 | Traditional | PDF ↗ |
| K952736 | PERCENT OXYGEN SENSOR | Analytical Industries, Inc. | 1995-10-18 | Traditional | PDF ↗ |
| K953351 | SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS | Seatronics Co. | 1995-10-16 | Traditional | PDF ↗ |
| K941793 | OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) | Mountain Medical Equipment, Inc. | 1995-06-21 | Traditional | PDF ↗ |
| K944120 | FI02 SENSING MODULE | Core-M, L.P. | 1995-05-10 | Traditional | PDF ↗ |
| K942593 | OXYCHEK OXYGEN ANALYZER | Nidek Medical Products, Inc. | 1995-05-03 | Traditional | PDF ↗ |
| K944654 | OXYGEN CONCENTRATION INDICATOR | Aequitron Medical, Inc. | 1994-11-08 | Traditional | PDF ↗ |
| K935364 | MINIOX 1000 OXYGEN CONCENTRATION INDICATOR | Minesafety Appliances Co. | 1994-06-14 | Traditional | PDF ↗ |
| K922438 | PRO2 OXYGEN ANALYZER | Martech Medical Products, Inc. | 1993-03-05 | Traditional | PDF ↗ |
| K922738 | VTI OXYGEN ANALYZER | Vascular Technology Incorporated | 1993-01-27 | Traditional | PDF ↗ |
| K920338 | COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR | Puritan Bennett Corp. | 1992-08-27 | Traditional | PDF ↗ |
| K913392 | OXYGEN SENSING DEVICE, MODIFICATION | Devilbiss Health Care, Inc. | 1992-07-17 | Traditional | PDF ↗ |
| K910381 | BIOCHEM TEMPERATURE/ FIO2 MODULE | Biochem International, Inc. | 1991-08-22 | Traditional | PDF ↗ |
| K911344 | CERION HAND HELD OXYGEN ANALYZER | Ceramatec, Inc. | 1991-06-18 | Traditional | PDF ↗ |
| K896359 | AG-820PA FI02 MODULE | Nihon Kohden America, Inc. | 1990-03-09 | Traditional | PDF ↗ |
| K896427 | SPACELABS' MODEL 90514, MULTIGAS ANALYZER | Spacelabs, Inc. | 1990-01-24 | Traditional | PDF ↗ |
| K890058 | VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM | Vascular Technology Incorporated | 1989-11-21 | Traditional | PDF ↗ |
| K894918 | HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. | Mennen Medical, Inc. | 1989-10-31 | Traditional | PDF ↗ |
| K891674 | NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 | Preemicare Corp. | 1989-08-31 | Traditional | PDF ↗ |
| K890144 | OXITRON OXYGEN SENSOR | Oxitron Medical Products | 1989-05-25 | Traditional | PDF ↗ |
| K890958 | OXITRON OXYGEN ANALYZER | Oxitron Medical Products | 1989-05-22 | Traditional | PDF ↗ |
| K882352 | MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT. | Clinical Information Systems, Inc. | 1988-11-02 | Traditional | PDF ↗ |
| K880378 | LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 | Lifecare Services, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K883254 | MULTINEX MONITOR (MODIFICATION) | Datascope Corp. | 1988-09-12 | Traditional | PDF ↗ |
| K882743 | OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR) | Ohmeda Medical | 1988-08-24 | Traditional | PDF ↗ |
| K881663 | OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES | Salter Labs | 1988-08-19 | Traditional | PDF ↗ |
| K881473 | SL01 OXYGEN ANALYZER | Salter Labs | 1988-06-16 | Traditional | PDF ↗ |
| K881472 | SL02 OXYGEN ANALYZER | Salter Labs | 1988-06-16 | Traditional | PDF ↗ |
| K875183 | LC OXYGEN ANALYZER | Ametek/Thermox Instruments Division | 1988-03-29 | Traditional | PDF ↗ |
| K880448 | CERION OXY THRESHOLD ALARM | Ceramatec, Inc. | 1988-03-21 | Traditional | PDF ↗ |
| K873068 | OXYGEN ANALYZER MODEL 800 SERIES | Salter Instrumentation, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K872001 | MODEL TPC-1A OXYGEN ANALYZER | Medical, Inc. | 1987-06-15 | Traditional | PDF ↗ |
| K871337 | M-2 OXYGEN/TEMPERATURE MONITOR | Bio-Med Devices, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K863158 | MODEL T-1 OXYGEN ANALYZER | Chrysalis Systems, Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K863806 | MODEL A-1 OXYGEN ANALYZER | Medical, Inc. | 1986-10-15 | Traditional | PDF ↗ |
| K862113 | NO. 100352 GALVANIC OXYGEN SENSOR | Vascular Technology Incorporated | 1986-06-19 | Traditional | PDF ↗ |
| K861625 | SERVO GAS MONITOR 120 | Siemens Elema AB | 1986-05-02 | Traditional | PDF ↗ |
| K854799 | EMERSON MODEL 3MV-OAA ALARM MODULE | J. H. Emerson Co. | 1985-12-11 | Traditional | PDF ↗ |
| K854599 | VICKERS MEDICAL MODEL 273 OXYGEN MONITOR | Vickers , Ltd. | 1985-11-27 | Traditional | PDF ↗ |
| K852823 | DMA OXYGEN MONITOR | Ferguson Medical | 1985-10-29 | Traditional | PDF ↗ |
| K853082 | OHMEDA 5120 OXYGEN MONITOR | Ohmeda Medical | 1985-07-31 | Traditional | PDF ↗ |
| K852275 | VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR | Vascular Technology Incorporated | 1985-06-20 | Traditional | PDF ↗ |
| K843847 | O2 TEST | Erich Jaeger, Inc. | 1984-10-12 | Traditional | PDF ↗ |
| K840645 | ENGSTROM ELIZA DUO CO2 & O2 ANALYZ | Gambro, Inc. | 1984-04-05 | Traditional | PDF ↗ |
| K840565 | MONITOR 5590- ANALYZER 5595EC | Hudson Oxygen Therapy Sales Co. | 1984-04-02 | Traditional | PDF ↗ |
| K840392 | NOVOX OXYGEN ANALYZER 400 | Novametrix Medical Systems, Inc. | 1984-02-27 | Traditional | PDF ↗ |
| K840361 | OXYGEN ANALYZER 200 | Salter Labs | 1984-02-17 | Traditional | PDF ↗ |
| K833496 | OXYGEN MONITOR/CONTROLLER | Oxequip Health Ind. | 1983-12-16 | Traditional | PDF ↗ |
| K833995 | MINI OX II | Catalyst Research Corp. | 1983-12-12 | Traditional | PDF ↗ |
| K831522 | BIO-TEK PERCENT OXYGEN MONITOR 74222 | Bio-Tek Instruments, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K831238 | OXYMED | Draeger Medical, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K830446 | OXYGEN MONITOR OHIO 5100 | Airco/Ohio Medical Products | 1983-03-24 | Traditional | PDF ↗ |
| K830124 | OPTION A02 MODEL 15202A | Hewlett-Packard Co. | 1983-02-09 | Traditional | PDF ↗ |
| K823449 | RESPIRATORY GAS ANALYZER | Thoratec Laboratories Corp. | 1983-01-05 | Traditional | PDF ↗ |
| K823374 | OXYGEN MONITOR IL 408 | Instrumentation Laboratory CO | 1982-12-09 | Traditional | PDF ↗ |
| K823232 | YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP | Yellow Springs Instrument Co., Inc. | 1982-12-07 | Traditional | PDF ↗ |
| K823231 | YSI #2600 MULTI-CHANNEL DUAL-DISPLAY | Yellow Springs Instrument Co., Inc. | 1982-12-07 | Traditional | PDF ↗ |
| K822608 | MK 808 SERIES NASAL OXYGEN SAMPLER | Instrumentation Industries, Inc. | 1982-10-04 | Traditional | PDF ↗ |
Product code CCL · Class II · Anesthesiology. Data: openFDA.