Atlas FDA

CCL

122 FDA 510(k) clearances · Product code

87 daysmedian time to decision
260 days90th percentile
122clearances measured

FDA profile

Official device name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1720
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2008: 2 · 2009: 2 · 2010: 5 · 2011: 4 · 2012: 5 · 2014: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) (K261389)Salter Labs2026-07-30
OxyMinder Pro (10310) (K251245)Bio-Med Device, Inc.2025-08-11
Smart Check O2 (MA0236) (K250002)Life Spark Medical, LLC2025-04-24
Maxtec MaxO2 ME+p (K221734)Maxtec, LLC2023-04-01
Percent Oxygen Sensors (K213933)Careox, LLC2022-08-19
OxyMinder (K213948)Bio-Med Devices, Inc.2022-03-17
Accu O2 Oxygen Analyzer (K173807)Precision Medical, Inc.2018-05-02
MaxO2ME (K153659)Maxtec, LLC2016-06-10
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES (K123195)GE Healthcare Finland Oy2013-02-28
ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (K122290)Envitec-Wismar GmbH2013-01-23
ULTRAMAXO2 OXYGEN ANALYER (K112402)Maxtec, LLC2011-12-14
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106 (K082655)Envitec-Wismar GmbH2008-11-25
DIGIFLO CONCENTRATOR ANALYZER (K072469)Digiflo, Inc.2008-01-03
PRECISION OXYGEN MONITOR (K063096)Precision Medical, Inc.2007-02-27
MAXO2 CU (K063488)Maxtec, Inc.2007-02-22
OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M (K053407)Analytical Industries, Inc.2006-04-05
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC (K051092)GE Healthcare2005-05-25
OXYGEN MEDICELS, CITICELS (K041773)City Technology Limited2004-07-15
MAXO2+, MODEL A AND AE (K040484)Maxtec, Inc.2004-06-09
RX300 OXYGEN ANALYZER (K024228)Teledyne Analytical Instruments2003-07-17
MX 300 OXYGEN MONITOR (K024155)Teledyne Analytical Instruments2003-07-17
OXICHECK (K023565)Caradyne, Ltd.2003-03-28
PRIMA OXYGEN MONITOR (K010318)Penlon , Ltd.2001-07-23
'ALL 2000' % OXYGEN ANALYZER (K002382)Analytical Industries, Inc.2001-03-14
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I (K010382)Sensidyne, Inc.2001-03-01
M-XX OXYGEN SENSORS (K002384)International Business Strategies2000-12-15
SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR (K000700)Sensidyne, Inc.2000-08-31
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 (K001095)Teledyne Analytical Instruments2000-06-30
TED 200T7 OXYGEN MONITOR (K990403)Teledyne Electronic Technologies2000-02-03
TED 60T OXYGEN ANALYZER (K990457)Teledyne Electronic Technologies1999-11-09
SIEMENS FIO2 SENSOR (K991884)Siemens Medical Solutions USA, Inc.1999-11-03
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS) (K984295)Invacare Corp.1999-07-09
PRO2 CHECK OXYGEN INDICATOR (K983500)Medical Technology Specialists, Inc.1999-03-17
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 (K982619)Hewlett-Packard Co.1998-08-12
MODEL 02 OXYGEN ANALYZER (K971084)Oxigraf, Inc.1998-07-21
VACU*MED GOLD EDITION OXYGEN GAS ANALYZER (K973545)Vacumed, Div. of Vacumetrics, Inc.1998-05-26
CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS (K972992)Ceramatec, Inc.1998-03-30
HANDI OXYGEN ANALYZER (K973282)Ceramatec, Inc.1998-03-04
TED 191 (K963177)Teledyne Brown Engineering1997-11-13
VENTREX OXYGEN SENSOR (K963415)Ventrex, LLC1996-11-25
GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION (K943824)Ametek, Inc.1996-11-01
MINIOX 3000 OXYGEN MONITOR (K961644)Minesafety Appliances Co.1996-07-25
OXYCHECK OXYGEN MONITOR (K951038)Oxycheck, Inc.1996-01-11
PERCENT OXYGEN SENSOR (K952736)Analytical Industries, Inc.1995-10-18
SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS (K953351)Seatronics Co.1995-10-16
OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) (K941793)Mountain Medical Equipment, Inc.1995-06-21
FI02 SENSING MODULE (K944120)Core-M, L.P.1995-05-10
OXYCHEK OXYGEN ANALYZER (K942593)Nidek Medical Products, Inc.1995-05-03
OXYGEN CONCENTRATION INDICATOR (K944654)Aequitron Medical, Inc.1994-11-08
MINIOX 1000 OXYGEN CONCENTRATION INDICATOR (K935364)Minesafety Appliances Co.1994-06-14
PRO2 OXYGEN ANALYZER (K922438)Martech Medical Products, Inc.1993-03-05
VTI OXYGEN ANALYZER (K922738)Vascular Technology Incorporated1993-01-27
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR (K920338)Puritan Bennett Corp.1992-08-27
OXYGEN SENSING DEVICE, MODIFICATION (K913392)Devilbiss Health Care, Inc.1992-07-17
BIOCHEM TEMPERATURE/ FIO2 MODULE (K910381)Biochem International, Inc.1991-08-22
CERION HAND HELD OXYGEN ANALYZER (K911344)Ceramatec, Inc.1991-06-18
AG-820PA FI02 MODULE (K896359)Nihon Kohden America, Inc.1990-03-09
SPACELABS' MODEL 90514, MULTIGAS ANALYZER (K896427)Spacelabs, Inc.1990-01-24
VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM (K890058)Vascular Technology Incorporated1989-11-21
HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP. (K894918)Mennen Medical, Inc.1989-10-31
NEONATAL ENVIRONMENTAL MONITOR, MODEL 275 (K891674)Preemicare Corp.1989-08-31
OXITRON OXYGEN SENSOR (K890144)Oxitron Medical Products1989-05-25
OXITRON OXYGEN ANALYZER (K890958)Oxitron Medical Products1989-05-22
MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT. (K882352)Clinical Information Systems, Inc.1988-11-02
LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 (K880378)Lifecare Services, Inc.1988-09-30
MULTINEX MONITOR (MODIFICATION) (K883254)Datascope Corp.1988-09-12
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR) (K882743)Ohmeda Medical1988-08-24
OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES (K881663)Salter Labs1988-08-19
SL01 OXYGEN ANALYZER (K881473)Salter Labs1988-06-16
SL02 OXYGEN ANALYZER (K881472)Salter Labs1988-06-16
LC OXYGEN ANALYZER (K875183)Ametek/Thermox Instruments Division1988-03-29
CERION OXY THRESHOLD ALARM (K880448)Ceramatec, Inc.1988-03-21
OXYGEN ANALYZER MODEL 800 SERIES (K873068)Salter Instrumentation, Inc.1987-10-20
MODEL TPC-1A OXYGEN ANALYZER (K872001)Medical, Inc.1987-06-15
M-2 OXYGEN/TEMPERATURE MONITOR (K871337)Bio-Med Devices, Inc.1987-06-05
MODEL T-1 OXYGEN ANALYZER (K863158)Chrysalis Systems, Inc.1986-11-13
MODEL A-1 OXYGEN ANALYZER (K863806)Medical, Inc.1986-10-15
NO. 100352 GALVANIC OXYGEN SENSOR (K862113)Vascular Technology Incorporated1986-06-19
SERVO GAS MONITOR 120 (K861625)Siemens Elema AB1986-05-02
EMERSON MODEL 3MV-OAA ALARM MODULE (K854799)J. H. Emerson Co.1985-12-11
VICKERS MEDICAL MODEL 273 OXYGEN MONITOR (K854599)Vickers , Ltd.1985-11-27
DMA OXYGEN MONITOR (K852823)Ferguson Medical1985-10-29
OHMEDA 5120 OXYGEN MONITOR (K853082)Ohmeda Medical1985-07-31
VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR (K852275)Vascular Technology Incorporated1985-06-20
O2 TEST (K843847)Erich Jaeger, Inc.1984-10-12
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ (K840645)Gambro, Inc.1984-04-05
MONITOR 5590- ANALYZER 5595EC (K840565)Hudson Oxygen Therapy Sales Co.1984-04-02
NOVOX OXYGEN ANALYZER 400 (K840392)Novametrix Medical Systems, Inc.1984-02-27
OXYGEN ANALYZER 200 (K840361)Salter Labs1984-02-17
OXYGEN MONITOR/CONTROLLER (K833496)Oxequip Health Ind.1983-12-16
MINI OX II (K833995)Catalyst Research Corp.1983-12-12
BIO-TEK PERCENT OXYGEN MONITOR 74222 (K831522)Bio-Tek Instruments, Inc.1983-09-12
OXYMED (K831238)Draeger Medical, Inc.1983-05-09
OXYGEN MONITOR OHIO 5100 (K830446)Airco/Ohio Medical Products1983-03-24
OPTION A02 MODEL 15202A (K830124)Hewlett-Packard Co.1983-02-09
RESPIRATORY GAS ANALYZER (K823449)Thoratec Laboratories Corp.1983-01-05
OXYGEN MONITOR IL 408 (K823374)Instrumentation Laboratory CO1982-12-09
YSI #2600 MULTI-CHANNEL DUAL-DISPLAY (K823231)Yellow Springs Instrument Co., Inc.1982-12-07
YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP (K823232)Yellow Springs Instrument Co., Inc.1982-12-07
MK 808 SERIES NASAL OXYGEN SAMPLER (K822608)Instrumentation Industries, Inc.1982-10-04
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Every clearance here is in the API, with alerts when new ones post.