| VisuBreath (K261633) | Affirm Medical Technologies II, LLC | 2026-07-14 |
| Capnostream™35 Portable Respiratory Monitor (PM35MN) (K253030) | Covidien, LLC | 2026-05-01 |
| Medical Gas Analyzer (AG200) (K250148) | Prior Care Science Technology, Ltd. | 2025-08-28 |
| TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (K243956) | Nihon Kohden Corporation | 2025-06-10 |
| 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (K251216) | Barbaras Development, Inc. | 2025-06-04 |
| AIM (N/A) (K240937) | Inventeur, LLC | 2024-12-16 |
| AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (K230915) | Vyaire Medical, Inc. | 2024-11-12 |
| MicroTrend System (K212425) | Exostat Medical, Inc. | 2024-11-07 |
| Oxy2Pro (K222511) | Southmedic, Inc. | 2023-11-21 |
| Endure ETCO2/02 Nasal Cannula (K213767) | Endure Industries, Inc. | 2023-09-12 |
| CO2 Mainstream Sensor (K221118) | Draegerwerk AG & CO Kgaa | 2023-04-05 |
| XChange Device, XChange System (K210112) | Pneuma Therapeutics, Inc. | 2023-01-30 |
| Endoscopy Oxygen Mask (K220533) | Engineered Medical Systems, Inc. | 2022-11-16 |
| Microstream CO2 NanoPod (K213911) | Covidien, LLC | 2022-07-29 |
| CARESCAPE CO2 Microstream parameter (K213518) | Covidien, LLC | 2022-04-12 |
| CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories (K211171) | GE Healthcare Finland Oy | 2021-10-21 |
| Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector (K203762) | Covidien | 2021-09-17 |
| EMMA Capnograph (K201590) | Masimo Corporation | 2021-03-29 |
| Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ (K210019) | Unimed Medical Supplies, Inc. | 2021-03-04 |
| CO2 Sidestream Module (K192488) | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-22 |
| CO2 Mainstream Module (K192446) | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-21 |
| Capnostream 35 Portable Respiratory Monitor (K200594) | Oridion Medical 1987 , Ltd. | 2020-04-27 |
| Altera gas Sampling Lines (K192563) | Meditera Tibbi Malzeme San VE Tic AS | 2020-01-17 |
| Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric (K190824) | Bluepoint Medical GmbH & Co. KG | 2019-12-18 |
| MaxCap Ped and MaxCap Neo (K182362) | Maxtec, LLC | 2019-05-23 |
| CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO (K183394) | GE Healthcare Finland Oy | 2019-05-01 |
| Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line (K181624) | Oridion Medical 1987 , Ltd. | 2019-03-22 |
| Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line (K181467) | Oridion Medical 1987 , Ltd. | 2019-02-08 |
| CO2 Sampling Line (K181981) | Tylenol Medical Instruments Co., Ltd. | 2019-02-06 |
| MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly (K180902) | Medipines Corporation | 2019-01-11 |
| Capnograph and Oximeter (K170820) | Cmi Health, Inc. | 2018-07-18 |
| SuperNO2VA Et Device (K173147) | Revolutionary Medical Devices, Inc. | 2018-06-20 |
| ETCO2 Sensor (K171828) | Orantech, Inc. | 2018-05-31 |
| Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable (K171678) | Vyaire Medical, Inc. | 2018-04-30 |
| Panoramic Oxygen Mask (POM) (K172365) | Pom Medical, LLC | 2018-04-19 |
| OmniCap (K171235) | Respirion, Inc. | 2018-01-04 |
| IntelliVue Capnography Extension, IntelliVue Microstream Extension (K172904) | Philips Medizin Systeme Boeblingen GmbH | 2017-12-26 |
| Nihon Kohden CO2 Monitor (K171765) | Nihon Kohden Corporation | 2017-10-11 |
| CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories (K171028) | GE Healthcare Finland Oy | 2017-08-17 |
| OC-FLEX Flexible IntraOral Cannula (K161250) | Venture Therapeutics, Inc. | 2017-03-17 |
| TG-970P CO2 Sensor Kit (K161860) | Nihon Kohden Corporation | 2017-02-24 |
| Westmed Gas Sampling Cannula with O2 delivery (K162343) | Westmed, Inc. | 2016-12-14 |
| Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines (K151421) | Salter Labs | 2016-03-10 |
| CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX (K150245) | GE Healthcare Finland Oy | 2015-07-17 |
| Capnostream 35 Portable Respiratory Monitor (K150272) | Oridion Medical 1987 , Ltd. | 2015-07-17 |
| CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style (K143127) | Dispo-Med (Malaysia) Sdn Bhd | 2015-02-13 |
| SOFTECH Plus ETCO2 Cannula (K143469) | Teleflexmedical, Inc. | 2015-02-12 |
| CO2 monitoring line with and without in-line filter (K143150) | Besmed Health Business Corp | 2015-02-05 |
| IntelAir Nasal Airway Support System (K142467) | Abeon Medical Corporation | 2014-11-24 |
| CAPNOSTREAM20P WITH HIFI C02 MONITORING (K123690) | Oridion Medical 1987 , Ltd. | 2014-08-05 |
| SOFTECH PLUS ETC02 CANNULA (K132946) | Teleflexmedical, Inc. | 2014-06-04 |
| CO2 MONITORING LINE, CO2 MONITORING LINE WITH FILTER (K133516) | Flexicare | 2014-04-30 |
| DUALGUARD (K140473) | Flexicare Medical, Ltd. | 2014-04-10 |
| FLOCAP (K133540) | Maxtec, Inc. | 2014-03-28 |
| O2 NASAL CANNULA WITH CO2 MONITORING (K140113) | Flexicare Medical, Ltd. | 2014-03-06 |
| AIRWAY SUPPORT SYSTEM / AIRPORT (K131506) | Abeon Medical Corporation | 2014-03-06 |
| CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), (K131410) | Southmedic, Inc. | 2014-01-13 |
| M1 CAPNOGRAPHY MASK (K133806) | Monitor Mask, Inc. | 2013-12-31 |
| CAPNOMASK (K131339) | Mediplus , Ltd. | 2013-11-25 |
| TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T) (K122214) | Nihon Kohden Corp. | 2013-05-21 |
| CAPNO MODULE, 92517 (K130112) | Spacelabs Healthcare | 2013-03-21 |
| DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER (K122075) | Intersurgical, Inc. | 2012-12-20 |
| MICROSTREAM FILTERLINE ICU (K121927) | Oridion Medical 1987 , Ltd. | 2012-11-29 |
| IRMA C02 MODEL 200101; IRMA AX 200601 (K123043) | Phasein AB | 2012-10-25 |
| CAPNOSTREAM20P WITH AI/ODI (K112368) | Oridion Medical 1987 , Ltd. | 2012-07-19 |
| CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR (K112840) | Seebreath AB | 2012-07-13 |
| CAPNOGRAPHY PAD (92516) (K121017) | Spacelabs Healthcare | 2012-07-13 |
| END TIDAL CO2 NASAL CANNULA (K120518) | Care Fusion | 2012-05-04 |
| GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS (K110594) | Nihon Kohden Corp. | 2011-10-28 |
| ISA CO2, ISA AX+, ISA OR+ (K103604) | Phasein AB | 2011-04-06 |
| CAPNOSTREAM20 WITH MICROMEDICO2 MODULE (K094012) | Oridion Capnography, Inc. | 2010-05-12 |
| INFINITY MCABLE - MAINSTREAM CO2 (K100941) | Draeger Medical AG & Co. KG | 2010-04-23 |
| SMART CAPNOLINE GUARDIAN (K093388) | Oridion Medical 1987 , Ltd. | 2010-03-04 |
| ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE (K093525) | Ventlab Corp. | 2009-12-10 |
| NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P (K083456) | Nihon Kohden America, Inc. | 2009-03-02 |
| NEO-STAT CO2 <KG (K083056) | Mercury Medical | 2009-02-23 |
| TWINGUARD WITH CAPNOGRAPH ACCESSORY (K080527) | Trawax Pty Limited | 2008-10-31 |
| VEO MULTIGAS MONITOR FOR POCKET PC (K081601) | Phasein AB | 2008-09-04 |
| VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA (K063813) | Ventlab Corp. | 2008-03-26 |
| EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) (K072813) | Phasein AB | 2007-12-28 |
| YG-125T AND YG-135T NASAL ADAPTER (K072843) | Nihon Kohden America, Inc. | 2007-11-29 |
| PEDI CO2 EASY (K072220) | Westmed, Inc. | 2007-08-23 |
| CO2 EASY (K070128) | Westmed, Inc. | 2007-02-15 |
| EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG) (K063167) | Phasein AB | 2007-02-06 |
| CARBON DIOXIDE MONITOR, MODEL OLG-2800A (K062115) | Nihon Kohden America, Inc. | 2006-12-27 |
| INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A (K053204) | Draeger Medical AG & Co. Kgaa | 2006-02-03 |
| LOFLO C5 CO2 SENSOR (K053174) | Respironics Novametrix, LLC | 2006-01-12 |
| PRO-FLOW MULTIPURPOSE CANNULA (K053063) | Pro-Tech Services, Inc. | 2005-12-13 |
| DATEX-OHMEDA S/5 INTERFACE MODULE E-INT (K052880) | GE Healthcare | 2005-11-02 |
| DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES (K052582) | GE Healthcare | 2005-10-14 |
| VEO MULTIGAS MONITOR FOR POCKET PC, MODEL 400221 (K051857) | Weissburg Associates | 2005-09-15 |
| DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES (K052167) | GE Healthcare | 2005-09-08 |
| C-CO2 COLORIMETRIC CO2 INDICATOR (K050066) | Marquest Medical Products, Inc. | 2005-03-01 |
| SMART BITEBLOC (K042665) | Oridion Medical 1987 , Ltd. | 2004-11-23 |
| CAPNOSTAT 5 (K042601) | Respironics Novametrix, Inc. | 2004-11-19 |
| CAP-ONE, MODEL TG-920P (K040875) | Nihon Kohden America, Inc. | 2004-10-15 |
| EMG - ESSENTIAL GAS MODULE, MODEL M1013A (K041956) | Draeget Medical AG & Co. Kgaa | 2004-08-09 |
| MODIFICATION TO NICO WITH MARS, MODEL 7300 (K041450) | Respironics Novametrix, Inc. | 2004-06-18 |
| MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR (K040847) | Draeger Medical, Inc. | 2004-06-17 |
| POLARIS 2004 CAPNOGRAPH (K040011) | Oridion , Ltd. | 2004-05-13 |