| MESI mTABLET SPIRO (K251777) | Mesi D.O.O. | 2026-03-02 |
| TD-7301 Spirometer (TD-7301) (K241843) | Gostar Co., Ltd. | 2024-11-20 |
| Air Next (NVD-02) (K231416) | Nuvoair AB | 2024-01-18 |
| Spirobank Oxi (K230501) | Mir Medical International Research USA | 2023-12-15 |
| EasyOne Sky Spirometer (K230178) | Ndd Medizintechnik AG | 2023-10-19 |
| Alveoair Digital Spirometer (K222525) | Roundworks Technologies Private Limited | 2023-08-28 |
| Air Smart Extra Spirometer (K222443) | Feellife Health, Inc. | 2023-08-09 |
| SpiroHome Personal, SpiroHome Clinic (K213754) | Inofab Saglik Teknolojileri A.S | 2023-06-12 |
| ComPAS2 (K213872) | Morgan Scientific, Inc. | 2022-07-15 |
| Vitalograph Model 6000 Alpha (K212938) | Vitalograph Ireland, Ltd. | 2022-01-26 |
| Spirometer (K201493) | Mehow Innovative, Ltd. | 2021-06-10 |
| GoSpiro (K202837) | Monitored Therapeutics, Inc. | 2020-12-04 |
| Spirotrac (K201562) | Vitalograph Ireland, Ltd. | 2020-10-14 |
| Safey Pocket Spirometer (K201002) | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| Vitalograph Model 2120 In2itive eDiary (K200550) | Vitalograph Ireland, Ltd. | 2020-07-27 |
| Air Next (K183089) | Nuvoair AB | 2020-01-02 |
| Asthma Monitor AM3 (K183479) | Eresearch Technology | 2019-10-03 |
| Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option (K191013) | Welch Allyn, Inc. | 2019-09-10 |
| ComPAS2 (Computerized Pulmonary Analysis System) (K190568) | Morgan Scientific, Inc. | 2019-06-06 |
| Pulmonx Chartis Tablet Console (K180011) | Pulmonx Corporation | 2018-07-13 |
| GoSpiro (K163249) | Monitored Therapeutics, Inc. | 2017-03-24 |
| EasyOne Air Spirometer (K161536) | Ndd Medizintechnik AG | 2017-01-05 |
| Q13 SPIROLYSER® (K161676) | Fim Medical | 2016-10-20 |
| SpiroScout (K160116) | Ganshorn Medizin Electronic GmbH | 2016-10-07 |
| Vitalograph Model 6300 micro (K160253) | Vitalograph (Ireland) , Ltd. | 2016-08-26 |
| IQSense Flow Sensor Mouthpiece (K150515) | Sdi Diagnostics, Inc. | 2016-01-12 |
| Vitalograph Model 6600 Compact (K142642) | Vitalograph (Ireland) , Ltd. | 2015-06-30 |
| Vitalograph Model 6800 Pneumotrac (K142812) | Vitalograph (Ireland) , Ltd. | 2015-06-29 |
| MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX (K120577) | Medikro OY | 2015-06-24 |
| SpiroThor (K150137) | Cohero Health, LLC | 2015-05-27 |
| PULMONE MINIBOXPFT 2.0 (K141793) | Pulmone Advanced Medical Devices, Ltd. | 2015-03-06 |
| MICROBLAB, MICROLOOP (K141936) | Carefusion Germany 234 GmbH | 2014-12-29 |
| NeumoFilt Ergo/Neumo Filt BiteOn (K142303) | Medical Respiratory Devices S.L. | 2014-11-20 |
| VITALOGRAPH MODEL 7000 SPIROTRAC (K141546) | Vitalograph (Ireland) , Ltd. | 2014-09-03 |
| MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO (K133428) | Medikro OY | 2014-05-21 |
| ASTHMA MONITOR AM3 (K133722) | Eresearch Technology | 2014-05-08 |
| SPM-300 (K130322) | Bionet Co., Ltd. | 2013-11-15 |
| SPIROTEL (K130784) | Mir Medical Intl. Research Srl | 2013-10-30 |
| CCS-200 SPIROMETER (K123896) | Benson Medical Instruments Co. | 2013-09-10 |
| MINISPIR (K122384) | Mir Medical Intl. Research Srl | 2012-10-04 |
| ORBIT (K120880) | National Biomedical, LLC Dba Qrs Diagnostic | 2012-04-19 |
| MICRO I (K113096) | Carefusion Germany 234 GmbH | 2012-04-13 |
| SPIRODOC (K103530) | Medical International Research USA, Inc. | 2011-11-21 |
| CHARTIS CONSOLE (K111764) | Pulmonx, Inc. | 2011-11-10 |
| SPIRO PD (K103575) | Pmd Healthcare | 2011-11-09 |
| ALERKAN SPIROMETRY FILTER (K111587) | Alerkan, Ltd. | 2011-10-20 |
| MICRO DIARY SPIROMETER (K100928) | Viasys Respiratory Care, Inc. | 2011-03-07 |
| MASTERSCREEN IOS (K101873) | Carefusion Germany 234 GmbH | 2011-02-10 |
| VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 (K100687) | Vitalograph (Ireland) , Ltd. | 2010-10-16 |
| ASTRASONIC SPIROMETER, MODEL 29-8000 (K092813) | Sdi Diagnostics, Inc. | 2010-07-16 |
| SPIROPALM (K093174) | Cosmed Srl | 2010-02-26 |
| ASTHMA MONITOR AM3 (K092890) | Carefusion Germany 234 GmbH | 2010-01-13 |
| CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 (K090646) | Chest M.I., Inc. | 2009-07-23 |
| CHARTIS CONSOLE (K083199) | Pulmonx, Inc. | 2009-06-25 |
| EASY ON-PC SPIROMETER (K090034) | Ndd Medizitechnik AG | 2009-06-02 |
| ASTHMA MONITOR MODEL, AM1 (K090486) | Cardinal Health Germany 234 GmbH | 2009-05-06 |
| WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 (K082478) | Welch Allyn, Inc. | 2009-03-09 |
| THE PFT FILTER (K083233) | Pulmonary Filtration Technologies, LLC | 2009-03-02 |
| INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) (K083879) | Innovision A/S | 2009-02-23 |
| SPIRO-MASTER PC-10 SPIROMETRY SYSTEM (K080921) | Chest M.I., Inc. | 2009-01-21 |
| MODIFICATION TO MINISPIR, SPIROLAB III (K082766) | Mir Medical Intl. Research Srl | 2008-12-17 |
| VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) (K073155) | Vitalograph (Ireland) , Ltd. | 2008-06-04 |
| MEDDORNA WIRELESS PRN SPIROMETER 100 (K072722) | Meddorna, LLC | 2008-04-24 |
| SPIROBANK G (K072979) | Mir Medical Intl. Research Srl | 2007-12-26 |
| ASTRA 300 (K061571) | Sdi Diagnostics, Inc. | 2007-01-31 |
| ASTRAGUARD PULMONARY FUNCTION FILTER (K062913) | Sdi Diagnostics, Inc. | 2007-01-26 |
| PULMOLIFE (K061283) | Micro Medical, Ltd. | 2006-12-14 |
| MINISPIR; SPIROLAB III (K061875) | Mir Medical Intl. Research Srl | 2006-12-11 |
| SPIROBANK II (K061712) | Mir Medical Intl. Research Srl | 2006-12-01 |
| SPIROLAB, SPIROLAB II (K052140) | Mir Medical Intl. Research Srl | 2006-03-16 |
| FLOWHANDY ZAN100 USB (K052176) | Zan Messgerate GmbH | 2006-01-12 |
| KOKO LEGEND (K051572) | Pulmonary Data Services, Inc. | 2005-11-17 |
| WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE (K052158) | Welch Allyn, Inc. | 2005-09-08 |
| MODEL 2800 PFT FILTER (K051712) | Air Safety, Ltd. | 2005-09-01 |
| POLYTECH PULMONARY FUNCTION FILTER (K042758) | Polytechnic Resources, Inc. | 2005-08-29 |
| SPIROTEL (K043528) | Mir Medical Intl. Research Srl | 2005-07-19 |
| ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 (K050424) | Fim Medical | 2005-06-23 |
| SPIRO'AIR (K042595) | Morgan Scientific, Inc. | 2005-05-04 |
| ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN (K042058) | Clement Clarke Intl., Ltd. | 2005-03-23 |
| LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 (K033518) | Custom Plastic Products | 2004-03-10 |
| FLOSENSE II, MODEL 29-8040 (K033939) | Sdi Diagnostics, Inc. | 2004-01-30 |
| SPIROTEL, MODEL 29-1020 (K031643) | Sdi Diagnostics, Inc. | 2003-12-09 |
| MICROLAB SPIROMETER (K031102) | Micro Direct, Inc. | 2003-12-01 |
| GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 (K030917) | Collins Medical, Inc. | 2003-05-14 |
| IQTEQ SPIROMETER (K020102) | Iqteq Development | 2003-03-21 |
| GEM, MODEL 004110 (K030464) | Collins Medical, Inc. | 2003-03-14 |
| PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE (K023225) | Puritan Bennett Corp. | 2002-12-18 |
| COMPAS (K021200) | Morgan Scientific, Inc. | 2002-10-18 |
| KOKOMATE (K022276) | Ferraris Respiratory, Inc. | 2002-10-04 |
| PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM (K022103) | Puritan Bennett Corp. | 2002-09-27 |
| PULMOLAB EX671 EXERCISE TESTING SYSTEM (K020280) | Morgan Medical , Ltd. | 2002-09-24 |
| CLINDATALINK VERSION 1.0 FOR SPIROMETRY (K020004) | Compleware Corp. | 2002-07-24 |
| EMS PULMONARY FUNCTION TESTING FILTER (K013123) | Engineered Medical Systems | 2002-03-14 |
| SPL-50 SPIROLYSER (K010761) | Fim Medical | 2002-03-05 |
| SPIROLAB II, MODEL 29 (K013812) | Sdi Diagnostics, Inc. | 2002-02-11 |
| COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM) (K013752) | Morgan Scientific, Inc. | 2002-01-30 |
| SDI SB OFFICE, MODEL 29- (K011470) | Sdi Diagnostics, Inc. | 2001-10-12 |
| PC FLOW + (K001528) | Spirometrics Medical Equipment Co. | 2001-01-18 |
| SENSAIRE DIAGNOSTIC SPIROMETER (K001278) | Qrs Diagnostic, LLC | 2000-11-29 |
| BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE (K002499) | Brentwood Medical Technology Corp. | 2000-11-08 |