Spirometer, Therapeutic (Incentive)
FDA product code BWF · Class II (moderate risk) · 21 CFR 868.5690 · Anesthesiology
108510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Dhd Healthcare Corp. 5
- Health Products, Inc. 4
- Dhd Medical Products Div. Diemolding Corp. 4
- Dhd Diemolding Healthcare Div. 3
- Trudell Medical International 3
- Chesebrough-Pond'S U.S.A. Co. 3
- Advanced Circulatory Systems, Inc. 3
- Besmed Health Business Corp 2
- Monaghan Medical Corp. 2
- Health Scan, Inc. 2
- Leventon, S.A. 2
- Vitalograph , Ltd. 2
- Diemolding Corp. 2
- Airlife, Inc. 2
- Empire Plastics Manufacturer 2
- Pari Holding Co. 2
- Dytek Corp. 2
- Pari Respiratory Equipment, Inc. 2
- MBA Healthcare Products, Inc. 2
- Trudell Medical Intl. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241152 | InSeeBWF · Traditional | Tidal Medical Technologies, LLC | 08/21/2025SE |
| K233855 | AllPEPBWF · Traditional | Enchant Tek Co. , Ltd. | 02/02/2024SE |
| K221058 | LungTrainer (MD2 & MD3)BWF · Traditional | Lung Trainers, LLC | 07/05/2023SE |
| K222018 | Breathe+BWF · Traditional | Peep Medical, LLC Dba Go2 Devices | 06/02/2023SE |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF · Traditional | Medline Industries, Inc. | 10/25/2022SE |
| K203378 | PulsehalerBWF · Traditional | Respinova, Ltd. | 03/31/2021SE |
| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
| K181660 | Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional | Smiths Medical | 10/24/2019SE |
| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | Trudell Medical International | 08/16/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | Teleflexmedical, Inc. | 07/01/2019SE |
| K173918 | VersaPAP Positive Airway Pressure (PAP) DeviceBWF · Traditional | Trudell Medical International | 08/17/2018SE |
| K172388 | Vpod ItprBWF · Traditional | Advanced Circulatory System, A Wholly Owned… | 12/22/2017SE |
| K160837 | Medinet Incentive Spirometers - RespiprogramBWF · Traditional | Medinet Srl | 02/23/2017SE |
| K163091 | VibraPEPBWF · Traditional | Medica Holdings, LLC | 02/21/2017SE |
| K160636 | iPEP System and vPEPBWF · Traditional | D R Burton Healthcare, LLC | 08/03/2016SE |
| K150044 | O-PepBWF · Traditional | Pari Respiratory Equipment, Inc. | 05/27/2016SE |
| K153441 | VibraPEPBWF · Traditional | Medica Holdings, LLC | 03/25/2016SE |
| K150173 | Aerobika OPEP Devive with ManometerBWF · Special | Trudell Medical International | 10/15/2015SE |
| K140772 | Aerosure MedicBWF · Traditional | Actegy , Ltd. | 12/19/2014SE |
| K141355 | Volumetric Incentive SpirometerBWF · Traditional | Besmed Health Business Corporation | 09/03/2014SE |
| K133873 | Triball Incentive SpirometerBWF · Traditional | Besmed Health Business Corp | 04/04/2014SE |
| K123400 | Aerobika Positive Expiratory Pressure DeviceBWF · Traditional | Trudell Medical Intl. | 05/16/2013SE |
| K091557 | Lung Flute TherapeuticBWF · Traditional | Medical Acoustics | 01/04/2010SE |
| K090829 | Pari Pep SBWF · Traditional | Pari Respiratory Equipment, Inc. | 07/21/2009SE |
| K080299 | Respifit S, Model RS-LR1001004BWF · Traditional | Eumedics Medizintechnik Und Marketing GmbH | 01/13/2009SE |
| K070490 | Cirqlator Intrathoracic Pressure Regulator (Itpr)BWF · Traditional | Advanced Circulatory Systems, Inc. | 06/20/2007SE |
| K053149 | Spiro-BallBWF · Traditional | Leventon, S.A. | 12/13/2005SE |
| K040084 | Lifestyle Circulatory EnhancerBWF · Abbreviated | Advanced Circulatory Systems, Inc. | 04/07/2004SE |
| K033401 | Modification to Resqpod Circulatory EnhancerBWF · Special | Advanced Circulatory Systems, Inc. | 11/20/2003SE |
| K022906 | Resqpod Circulatory EnhancerBWF · Abbreviated | Cprx, LLC | 06/11/2003SE |
| K012368 | AeropepBWF · Traditional | Trudell Medical Intl. | 02/12/2002SE |
| K002768 | AcapellaBWF · Traditional | Dhd Healthcare Corp. | 12/05/2000SE |
| K003146 | Cliniflo Incentive SpirometerBWF · Traditional | Dhd Healthcare Corp. | 11/21/2000SE |
| K994074 | Tri-BallBWF · Traditional | Leventon, S.A. | 06/08/2000SE |
| K000314 | Incentive SpirometerBWF · Traditional | Engineered Medical Systems | 04/12/2000SE |
| K992256 | Frolov's Respiration Training Device, FRTD-01BWF · Traditional | Intercontinental New Technologies, Inc. | 01/11/2000SE |
| K991561 | Roadrunner, Pep Therapy DeviceBWF · Traditional | Dhd Healthcare Corp. | 11/10/1999SE |
| K991300 | Boeing, Positive Airway Pressure (Pap) Therapy DeviceBWF · Traditional | Dhd Healthcare Corp. | 07/12/1999SE |
| K983308 | RC Cornet, Model #44F50BWF · Traditional | Pari Holding Co. | 06/04/1999SE |
| K984468 | Vital PepBWF · Traditional | Vital Signs, Inc. | 06/01/1999SE |
| K983467 | TherapepBWF · Traditional | Dhd Healthcare Corp. | 04/02/1999SE |
| K974848 | Mini-CiserBWF · Traditional | Hougen Mfg., Inc. | 08/06/1998SE |
| K972824 | The Breather Inspiratory/Expiratory Muscle TrainerBWF · Traditional | Pn Medical | 04/03/1998SE |
| K972042 | Pari Pep Therapy SystemBWF · Traditional | Pari Holding Co. | 08/05/1997SE |
| K970596 | DHD Emerald ProductBWF · Traditional | Dhd Diemolding Healthcare Div. | 05/16/1997SE |
| K954492 | Mercury Medical Expiratory Resistance Exerciser, ResistexBWF · Traditional | Mercury Medical | 10/21/1996SE |
| K962749 | Therapep W/Mouthpiece, W/Pediatric Mask, W/Small Mask, W/Large Mask…BWF · Traditional | Diemolding Corp. | 10/10/1996SE |
| K961077 | Pep (Positive Expiratory Pressure) Therapy DeviceBWF · Traditional | Healthscan Products, Inc. | 07/15/1996SE |
| K953055 | Mistassist Breathing ExerciserBWF · Traditional | The Merlin Corp. | 02/08/1996SE |
| K944412 | The BreatherBWF · Traditional | Pal Medical, Inc. | 04/26/1995SE |
| K944344 | Lung Technologies 5000 Therapeutic Incentive SpirometerBWF · Traditional | Lung Technologies, Inc. | 02/03/1995SE |
| K945118 | Expiratory Breathing ExerciserBWF · Traditional | Dhd Diemolding Healthcare Div. | 01/13/1995SE |
| K944900 | TherapepBWF · Traditional | Dhd Diemolding Healthcare Div. | 01/06/1995SE |
| K942919 | Mercury Expiratory Resistance ExerciserBWF · Traditional | Mercury Ent., Inc. D/B/A Mercury Medical | 09/19/1994SE |
| K912943 | Threshold 2X Inspiratory Muscle TrainerBWF · Traditional | Health Products, Inc. | 01/30/1992SE |
| K910138 | TVS II Electronic Incentive SpirometerBWF · Traditional | Monaghan Medical Corp. | 03/12/1991SE |
| K903489 | Thera-Mist TM Volumina Incent Spirometer, P40000BWF · Traditional | Pegasus Research Corp. | 12/10/1990SE |
| K900754 | Respirex 2BWF · Traditional | Diemolding Corp. | 03/15/1990SE |
| K893665 | Aerosol Inhalation MonitorBWF · Traditional | Vitalograph , Ltd. | 08/21/1989SE |
| K873540 | Aerobica - Lung ExerciserBWF · Traditional | MBA Healthcare Products, Inc. | 02/04/1988SE |
| K873579 | Ambu RMT ValveBWF · Traditional | Ambu, Inc. | 12/30/1987SE |
| K871904 | Total Lung Exerciser (Tle)BWF · Traditional | MBA Healthcare Products, Inc. | 07/08/1987SE |
| K871742 | Modified Use of Plex Inspiratory Muscle TrainerBWF · Traditional | Health Products, Inc. | 06/15/1987SE |
| K870514 | Threshold(Tm) Inspiratory Muscle TrainerBWF · Traditional | Health Products, Inc. | 03/31/1987SE |
| K864719 | Pflex Em(Tm) (Exercise Monitor)BWF · Traditional | Health Products, Inc. | 03/16/1987SE |
| K861564 | The Lung Gym (Xlator and Nlator)BWF · Traditional | El-Fax Company, Inc. | 08/07/1986SE |
| K851334 | Airlife Electronic Incentive SpirometerBWF · Traditional | American Pharmaseal Div. Ahsc | 08/06/1985SE |
| K844963 | VitapepBWF · Traditional | Vitalograph , Ltd. | 06/07/1985SE |
| K842369 | Elecath Infant Arterial & Venous CannuBWF · Traditional | Electro-Catheter Corp. | 08/27/1984SE |
| K842634 | Pflex Respiratory Muscle ExerciserBWF · Traditional | Health Scan, Inc. | 08/10/1984SE |
| K840239 | VoflexBWF · Traditional | Dhd Medical Products Div. Diemolding Corp. | 03/05/1984SE |
| K840418 | Inspiratory/Expiratory Muscle ExercisBWF · Traditional | Inspiron Corp. | 02/17/1984SE |
| K833337 | Volurex IIBWF · Traditional | Dhd Medical Products Div. Diemolding Corp. | 11/28/1983SE |
| K833012 | InspirometerBWF · Traditional | Kinetix | 11/08/1983SE |
| K832878 | Goal TenderBWF · Traditional | Dna Medical, Inc. | 10/14/1983SE |
| K831142 | Inspiratory Resistor KitBWF · Traditional | Dhd Medical Products Div. Diemolding Corp. | 06/03/1983SE |
| K821492 | BE#6006 Var. Resis. Inspir. MuscleBWF · Traditional | Instrumentation Industries, Inc. | 09/24/1982SE |
| K822359 | Spi-RiseBWF · Traditional | Certified Respiratory Services, Inc. | 08/27/1982SE |
| K821998 | RespicordBWF · Traditional | Novamed Products, Inc. | 07/30/1982SE |
| K820528 | Pflex TMBWF · Traditional | Health Scan, Inc. | 03/26/1982SE |
| K820606 | Monaghan's True Volume ExerciserBWF · Traditional | Monaghan Medical Corp. | 03/23/1982SE |
| K813476 | Ohio Volume Incentive SpirometerBWF · Traditional | Airco/Ohio Medical Products | 12/31/1981SE |
| K810641 | K-Med Encourager Incentive SpirometerBWF · Traditional | K-Med, Inc. | 05/13/1981SE |
| K801199 | Voldyne Volumetric Incentive Deep Br. ExBWF · Traditional | Chesebrough-Pond'S U.S.A. Co. | 06/04/1980SE |
| K800546 | Bunn Volumaire Respiratory ExerciserBWF · Traditional | The John Bunn Co. | 03/25/1980SE |
| K800386 | Argyle Tru-VolBWF · Traditional | Sherwood Medical Co. | 02/28/1980SE |
| K792598 | Disposable Incentive SpirometerBWF · Traditional | Hospitak, Inc. | 01/04/1980SE |
| K792571 | Counter UnitBWF · Traditional | Empire Plastics Manufacturer | 12/19/1979SE |
| K792217 | Air Incentive Spirometer, W/NebulizerBWF · Traditional | Airlife, Inc. | 11/27/1979SE |
| K792214 | Model TM2-BEHIND-THE-EAR TinnitusBWF · Traditional | Starkey Laboratories, Inc. | 11/27/1979SE |
| K791842 | MotivatorBWF · Traditional | Puritan Bennett Corp. | 10/01/1979SE |
| K791819 | Air Incentive SpirometerBWF · Traditional | Airlife, Inc. | 09/26/1979SE |
| K791015 | Volurex TMBWF · Traditional | Dhd Medical Products Div. Diemolding Corp. | 06/13/1979SE |
| K790744 | Lung Function Amplifier ExerciserBWF · Traditional | Empire Plastics Manufacturer | 04/27/1979SE |
| K781831 | Spirometer, Incentive Catalog # 1750BWF · Traditional | Hudson Oxygen Therapy Sales Co. | 12/15/1978SE |
| K782016 | Spirocare 108-BBWF · Traditional | Marion Laboratories, Inc. | 12/13/1978SE |
| K781731 | Incent-O-NebBWF · Traditional | B & F Medical Products, Inc. | 12/05/1978SE |
| K781838 | Calculator, with ChargerBWF · Traditional | C.R. Bard, Inc. | 11/21/1978SE |
| K781833 | Exerciser, Air-Eze IncentiveBWF · Traditional | Chesebrough-Pond'S U.S.A. Co. | 11/14/1978SE |
| K781669 | Respiratory Exercisor, Volume PulseBWF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/23/1978SE |
| K781245 | Lung Exer. Bag, Post-Op, ModifiedBWF · Traditional | Dytek Corp. | 09/20/1978SE |
| K780265 | Flow Reducing Angulation StandBWF · Traditional | Chesebrough-Pond'S U.S.A. Co. | 03/09/1978SE |
| K780037 | Exerciser, Resp., Deep BreathingBWF · Traditional | Medical Technologies of Georgia | 02/24/1978SE |
| K771532 | Spirometeo & Lung Exerciser, 4601BWF · Traditional | Boehringer Laboratories | 08/26/1977SE |
| K770619 | Exercisor, RespiratoryBWF · Traditional | Cutter Laboratories, Inc. | 04/07/1977SE |
| K770141 | Inspirometer Respiratory ExerciserBWF · Traditional | Medi, Inc. | 02/01/1977SE |
| K760762 | Incentive SpirometerBWF · Traditional | I-Spiron | 10/08/1976SE |
| K760167 | Bag, Post Operative Lung Exercizing BlowBWF · Traditional | Dytek Corp. | 08/06/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0874-2021 Class II | Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device…Shipping box may contain wrong model. | Smiths Medical ASD Inc. | 12/21/2020Terminated |