Instruments for functional explorations and therapeutic interventions
Pneumonology and respiratory physiopathology instruments
EMDN code Z1215
Manufacturers registered in Europe (EUDAMED) 149
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 326
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| POLYTECHNIC RESOURCES INC | United States | Polytech Noseclip Polytech Filter Polytech Mouthpiece | K042758 (2005) |
| Hans Rudolph, Inc. | United States | 5570 3L SYRINGE 5530 3L SYRINGE 4900 7L SYRINGE 5540 1L SYRINGE 5510 100ML SYRINGE 5550 1/2L SYRINGE | registered |
| A-M SYSTEMS, LLC | United States | Noseclip, Disposable , White, Foam Pad Disposable Blue PFT Nose Clip with Rubber Pads Disposable PFT Nose Clip with Foam Pads Disposable Blue PFT Nose Clip with Foam Pads Disposable PFT Nose Clip with Rubber Pads Disposable White PFT Nose Clip with Rubber Pads, Labeled D R Burton | registered |
| Ventec Life Systems, Inc. | United States | VOCSN Patient Breathing Package VOCSN HomeFill® Oxygen System VOCSN Patient Air Intake Filters VOCSN Power Supply VOCSN Fan Filters | registered |
| VYAIRE MEDICAL, INC. Present in Europe in other categories | United States | VMAX Avea FreeFlow™ AirLife™ Vyntus | K183567 (2019) |
| TRI-ANIM HEALTH SERVICES, INC. | – | Curaplex | registered |
| Medical Graphics Corp. Present in Europe in other categories | United States | SW Ascent 2.5 Download SW ASCENT 2.4.0 DOWNLOAD Medical Graphics MGC Diagnostics MCG Diagnostics MGC Diagnotics | K242809 (2024) |
| Sdi Diagnostics, Inc. | United States | mouthpiece Air Tube Safe T Check Safe T Check Astraguard Astra Spirometer | K150515 (2016) |
| Airsep Corp. | United States | NewLife Elite NewLife Intensity 10 NewLife Intensity VisionAire Focus FreeStyle | K150930 (2015) |
| Vacumed | – | White w/white foam noseclip 100/bx Multicolor noseclip 50/bag Snuffer noseclip 1000/bx Multicolor noseclip 500/bag Disposable Mouthpiece 35mm OD Disposable Mouthpiece 26mm OD | registered |
| Welch Allyn, Inc. Present in Europe in other categories | United States | Welch Allyn, Inc. | K191013 (2019) |
| Clement Clarke, Inc. | United Kingdom | Clement Clarke International Mini Wright In-Check Airzone Mini-Wright Able | K053156 (2006) |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | HUDSON RCI Medline | registered |
| NSPIRE HEALTH, INC. | United States | nSpire Health Hudson RCI | registered |
| BELLUSCURA PLC | United States | X-PLO2R DISCOV-R | K203086 (2021) |
| Percussionaire Corp. | United States | Percussionaire | K905236 (1991) |
| Abmrc, LLC | United States | BiWaze Clear Dual Lumen Circuit - Acute BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium BiWaze Clear Dual Lumen Circuit With Mouthpiece BiWaze Cough BiWaze Clear Dual Lumen Circuit With Face Mask - Child BiWaze Clear Dual Lumen Circuit With Trach Adapter | K260604 (2026) |
| Innovision A/S | United States | Innocor | K102047 (2011) |
| Shape Medical Systems, Inc. | United States | Shape-HF Shape Shape Vital Sign System Disposable Patient Interface with filter Shape II System Refurbished | K150888 (2016) |
| Acme United Corporation | United States | First Aid Only | registered |
| Utah Medical Products, Inc. Present in Europe in other categories | United States | DISPIRO | K791177 (1979) |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| VIVE HEALTH LLC Present in Europe in other categories | United States | VIVE ViveBreathe Vive Breathe | registered |
| ANESTHESIA ASSOCIATES, INC. | United States | AincA® | registered |
| Mv Life LLC | United States | OxyGo OxyHome | K252407 (2026) |
| ALLIANCE TECH MEDICAL INC | United States | All Flow Peds Disp Mthpc. InFloCone-V InFloCone All Flow Resp. Disp. Mthpc. All Flow Valved Ex.Mthpc. All Flow Mthpc. Adapter | registered |
| Dynarex Corporation | United States | Resp-O2 PFM Nose Clips, Adult / Pediatric Resp-O2 Durable Peak Flow Mouthpiece with One-Way Valve,Adult Resp-O2 Cardboard Peak Flow Mouthpiece, Disposable, Adult Resp-O2 Cardboard Peak Flow Mouthpiece, Disposable, Pediatric Resp-O2 Peak Flow Meter Full Range 50-800 L/min Resp-O2 Peak Flow Meter Low Range 50-300 L/min | registered |
| RESMED ASIA PTE. LTD. | – | Mobi External Battery Assembly Charger AC/DC with power cord Mobi Backpack Mobi Mounting Straps Mobi Shoulder Bag | registered |
| Salter Labs Present in Europe in other categories | United States | – | K863656 (1986) |
| CREATE BIOTECH CO., LTD. | Taiwan | Create Biotech | registered |
| Midmark Corp. Present in Europe in other categories | United States | Disposable Spirometer Mouthpieces Midmark Digital Spirometer Midmark Digital Spirometer w/Calibration Syringe Midmark IQspiro® Digital Spirometer Midmark IQspiro Digital Spirometer Midmark IQspiro® Digital Spirometer with Calibration Syringe | registered |
| GAS CONTROL EQUIPMENT LIMITED | United Kingdom | GCE Arya | registered |
| BOUND TREE MEDICAL, LLC | – | Curaplex | registered |
| Bionet Co., Ltd. Present in Europe in other categories | South Korea | Cardio Q50, Cardio Q70 Spiro Handle Cardio7 | K130322 (2013) |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| Vortran Medical Technology 1, Inc. Present in Europe in other categories | United States | VORTRAN-IPPB VORTRAN PercussiveNEB 2.0 VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port VORTRAN-IPPB with Manomter VORTRAN-IPPB with Water Trap VORTRAN PercussiveNEB | K003684 (2001) |
| FUTUREMED AMERICA, INC. | United States | FUTUREMED | K973456 (1998) |
| Invacare Corp. Present in Europe in other categories | United States | Invacare® HomeFill® Cylinder Bag Invacare® Platinum Oxygen Concentrator Invacare® Supply Line Assembly with Coiled Tubing Invacare® Perfecto2V Oxygen Concentrator | K203210 (2021) |
| Medi Soft SA | Belgium | TransAir3 SpiroAir BodyBox | registered |
| Monaghan Medical Corp. | United States | TruZone® TruPeak® Strive® | K123945 (2013) |
| Rhythm Healthcare, LLC | – | Rhythm Healthcare Rhythm Healthcare, LLC Rhythm | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | HUDSON RCI | registered |
| VECTRACOR INC | United States | Nose Clips 3L Calibration Syringe Plastic Mouthpieces (100) Orbit Spirometer | registered |
| Allied Medical, LLC Present in Europe in other categories | United States | BF | registered |
| CMI HEALTH INC. | United States | SpiroLoop SpiroLink 2 Pro | registered |
| FEELLIFE HEALTH INC. | China | Pressure gas blowpipe Mouthpiece Disposable Mouthpiece Spirometer | K222443 (2023) |
| Medi/Nuclear Corporation, Inc. | United States | Aero/Vent Plus SAFE-T-SHIELD Mouthpiece Insta/Vent - Safe-T-Shield Mouthpiece | K865093 (1987) |
| Morgan Scientific, Inc. | United States | ComPAS2 ComPAS | K213872 (2022) |
| Pulmone Advanced Medical Devices, Ltd. Present in Europe in other categories | United States | MiniBox MiniBox+ | K161295 (2016) |
| SAFEY MEDICAL DEVICES PRIVATE LIMITED | – | Safey Pocket Spirometer NxGen Pocket Spirometer Safey Peak Flow Meter NxGen Peak Flow Meter | registered |
| TREYMED INC | United States | Metaphor Flow Sensor | registered |
| Airlife, Inc. | United States | AirLife™ | K821128 (1982) |
| Cortex Biophysik GmbH | United States | CORTEX CPET System | K001631 (2001) |
| Covidien, LLC Present in Europe in other categories | United States | Puritan Bennett Nellcor | registered |
| D R BURTON HEALTHCARE, LLC | United States | T-PIECE ADAPTER | registered |
| DALTON MEDICAL CORPORATION | United States | DALTON OXYGEN CONCENTRATOR DALTON PORTABLE OXYGEN CONCENTRATOR | registered |
| Draeger Medical Systems, Inc. Present in Europe in other categories | United States | Respiratory Mechanics Flow Sensor – Adult/Pediatric Respiratory Mechanics Combined Flow/CO2 Sensor – Neonatal Respiratory Mechanics Sensor – Neonatal | registered |
| Drägerwerk AG & Co. KGaA Present in Europe in other categories | Germany | Infinity ID Flow Sensor SpiroLife Spirolog Flow Sensor | registered |
| GVS FILTER TECHNOLOGY UK LTD Present in Europe in other categories | United Kingdom | Nose Clip Spiroguard Spiroguard Noseclip-Cheek holder | registered |
| Instrumentation Industries, Inc. Present in Europe in other categories | United States | NC 12585 Nose Clip SH 7-47 Nose Clip BE 120-22D Mouthpiece Adapter | registered |
| Neotech Products LLC Present in Europe in other categories | United States | NeoSeal® | registered |
| PULMONX CORPORATION | United States | Pulmonx Chartis Tablet Console Chartis Console | K180011 (2018) |
| Shenzhen Konmed Technology Co., Ltd. Present in Europe in other categories | China | Konmed | registered |
| WESTMED, INC. | United States | Inline Water Trap OxyGo Inline Water Trap, For Oxygen Delivery Composite Respiratory Kit: Nationwide Medical | K954271 (1995) |
| Weoxy Co., LTD. | – | WeOxy | registered |
| ANDESFIT LIMITED | – | Andnesfit Health Andesfit | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Symmetry McKesson Symmetry Denhardt | registered |
| Benson Medical Instruments Co. | United States | – | K123896 (2013) |
| Corsano Health B.V. Present in Europe in other categories | Netherlands | Corsano CardioWatch 287-2 System | registered |
| Drive Devilbiss Healthcare | United States | Roscoe Medical | registered |
| ESSEX INDUSTRIES, INC. | – | Oxygen Generator and Liquifier | registered |
| FORA CARE INC. Present in Europe in other categories | Taiwan | FORA | registered |
| Fisher & Paykel Healthcare, Ltd. Present in Europe in other categories | New Zealand | FISHER & PAYKEL HEALTHCARE | registered |
| HCMED INNOVATIONS CO., LTD. | – | Aerogen®Go Pulmogine | registered |
| Koko, LLC | – | KoKo, LLC | registered |
| MAICO Diagnostics GmbH Present in Europe in other categories | United States | Benson | registered |
| MERCURY ENTERPRISES, INC. | – | Nose Clip Disp-o-seal | registered |
| Molecular Products , Ltd. | United States | RUGGED OXYGEN GENERATOR (ROG) | K240561 (2024) |
| Monitored Therapeutics, Inc. | United States | Turbine Assembly, Bagged for GoSpiro Spirometer GoSpiro | K202837 (2020) |
| On Site Gas Systems, Inc. | United States | POGS | K092636 (2010) |
| RESPIRATORY DELIVERY SYSTEMS INC | United States | Microchamber Microspacer | registered |
| TECHNOPULM LTD | Israel | STS | registered |
| Thornhill Research Inc Present in Europe in other categories | Canada | MOVES SLC | registered |
| WALGREEN CO. | – | Walgreens | registered |
| Caring Mill | – | caring mill | registered |
| Chongqing Moffy Innovation Technology Co., Ltd. | China | sonmol | K241338 (2024) |
| Cynosure, Inc. Present in Europe in other categories | United States | MEDI-FRIG | registered |
| D. E. Hokanson, Inc. Present in Europe in other categories | United States | Hokanson | K932812 (1994) |
| EON MEDITECH PRIVATE LIMITED | – | OSSEOUS-SnorOFF | registered |
| Engineered Medical Systems | United States | Pulmonary Function Filter | K013123 (2002) |
| GENIA MEDICAL, INC. | United States | AsthmaMD | registered |
| GERI-GENTLE CORPORATION | – | Oxygen Concentrator | registered |
| Guangzhou Red Elephant Medical Technology Co.,Ltd | – | SpiroLink | registered |
| HEALTHCARE LOGISTICS SYSTEMS LLC | – | Healthcare Logistics Systems | registered |
| HOME AIDE DIAGNOSTICS, INC. | – | Pure Comfort Adult Inhaler Spacer Chamber | registered |
| Honeywell Healthcare Solutions GmbH Present in Europe in other categories | – | Flow sensor | registered |
| Jones Medical Instrument Co. | United States | Satellite | K812001 (1981) |
| KNOX MEDICAL DIAGNOSTICS INC. | United States | Aluna | K232588 (2024) |
| Keybo Technologies Ltd | – | Keybo Technologies Ltd. CPR Face Shield | registered |
| MESI d.o.o. | Slovenia | MESI mTABLET SPIRO | K251777 (2026) |
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